Food Protein Induced Allergic Proctocolitis, Gut Microbiome, Infant Development
Conditions
Brief summary
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled trial with two arms evaluating IBF108F in breastfed infants with FPIAP. Assessments will be conducted over a 4-week study period with assessment of blood in stool, infant stooling, sleep, feeding, and growth. Safety will be evaluated through collection adverse events.
Interventions
DRUGINF108F probiotic
Oral suspension
DRUGPlacebo
Oral suspension
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks * Infants aged 1 - 90 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes * Infants must be exclusively breastfed or at least half of oral intake is from breast feeding or from expressed breast milk * A willing parent or legal guardian will sign the consent form either electronically or with a wet ink signature
Exclusion criteria
* Infants born earlier than 37 weeks of gestation * Infants who are exclusively formula-fed or less than half of oral intake is from breastfeeding or from expressed breast milk at the time of enrollment * Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies) * Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency * History of abdominal surgery or congenital abnormalities of the GI track, the cardiovascular system, the pulmonary system or the renal system * Antibiotic use (oral or systemic) within 7 days prior to enrollment * Mother's intent to feed non-study probiotics or solid food to their infant at any time during the study * Mothers with substance use disorder (SUD) or on Nicotine replacement therapy (NRT) * Infants who have consumed any B. infantis-containing probiotics since birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes to Gut Microbiome Composition | Baseline to Day 28 | Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes to Clinical Symptoms of FPIAP | Baseline to day 28 | We will collect information using questionnaires about infants' gastroesophageal reflux disease symptoms, feeding, sleep and stool frequency and consistency. The severity of infant GER will be quantified using the Infant Gastroesophageal Reflux Questionnaire (I-GERQ), with numeric scores. The minimum score is 0 and the maximum score is 25; scores \>7 provide 74% specificity and 94% sensitivity for diagnosing GERD. Higher I-GERQ scores/values are indicative of worse outcomes, worse reflux symptoms for the infant. The secondary outcome was reported as the absolute change from baseline in I-GERQ score; therefore, a higher value would be positive as the score is reduced significantly from baseline, which means reflux symptoms were improved. |
| Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log | Enrollment to Study Day 14 | Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized. |
| Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Baseline, Study Day 7, Study Day 14, Study Day 28 | The sleep will be captured using Infant Sleep Questionnaire, with 0-10 scales, 0 means worst sleep and 10 means excellent sleep for quantify the quality of infant's night sleep. Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized. |
Countries
United States
Participant flow
Recruitment details
Breastfed infants with FPIAP, w/ either grossly visible bloody stool or microscopic bloody stools, excl. other causes, will be recruited at PNW or MGH Pediatric GI clinic. They will be provided basic information about the study. We will ask potential participants to provide basic contact information and answer some study-specific questions as a pre-qualifier. Individuals who are interested to learn more will receive more details about the study, the informed consent, and study team contacts.
Participants by arm
| Arm | Count |
|---|---|
| INF108F INF108F | 10 |
| Placebo Placebo | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | INF108F | Placebo |
|---|---|---|---|
| Acid reflux medication taken after baby was born | 6 Participants | 2 Participants | 4 Participants |
| Age, Customized Age at Enrollment in weeks | 9.3 Weeks STANDARD_DEVIATION 3.02 | 9.2 Weeks STANDARD_DEVIATION 3.29 | 9.4 Weeks STANDARD_DEVIATION 2.72 |
| Age, Customized Age at First Physical Exam in weeks | 9.25 Weeks STANDARD_DEVIATION 2.88 | 9.1 Weeks STANDARD_DEVIATION 3.38 | 9.4 Weeks STANDARD_DEVIATION 2.27 |
| Age, Customized Gestational Age at Birth in weeks | 39.55 Weeks STANDARD_DEVIATION 0.96 | 39.55 Weeks STANDARD_DEVIATION 0.997 | 39.55 Weeks STANDARD_DEVIATION 0.923 |
| Baby ever consumed infant formula No | 10 Participants | 5 Participants | 5 Participants |
| Baby ever consumed infant formula Yes | 10 Participants | 5 Participants | 5 Participants |
| Baby ever consumed infant probiotics No | 15 Participants | 9 Participants | 6 Participants |
| Baby ever consumed infant probiotics Yes | 5 Participants | 1 Participants | 4 Participants |
| Baby ever consumed iron supplements No | 20 Participants | 10 Participants | 10 Participants |
| Baby ever consumed iron supplements Yes | 0 Participants | 0 Participants | 0 Participants |
| Baby ever consumed solid food No | 20 Participants | 10 Participants | 10 Participants |
| Baby ever consumed solid food Yes | 0 Participants | 0 Participants | 0 Participants |
| Birth Mode C-section | 6 Participants | 2 Participants | 4 Participants |
| Birth Mode Vaginal | 14 Participants | 8 Participants | 6 Participants |
| Delivered in a Hospital | 20 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Father ever had any type of allergy No | 12 Participants | 5 Participants | 7 Participants |
| Father ever had any type of allergy Yes | 8 Participants | 5 Participants | 3 Participants |
| Highest education of either parent in home is Bachelor's or Advanced degree | 20 Participants | 10 Participants | 10 Participants |
| Maternal antibiotic exposure during labor/delivery No | 12 Participants | 6 Participants | 6 Participants |
| Maternal antibiotic exposure during labor/delivery Unknown | 2 Participants | 1 Participants | 1 Participants |
| Maternal antibiotic exposure during labor/delivery Yes | 6 Participants | 3 Participants | 3 Participants |
| Mother ever consumed medication to treat acid reflux of GERD No | 7 Participants | 3 Participants | 4 Participants |
| Mother ever consumed medication to treat acid reflux of GERD Yes | 13 Participants | 7 Participants | 6 Participants |
| Mother ever had any type of allergy No | 15 Participants | 9 Participants | 6 Participants |
| Mother ever had any type of allergy Yes | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 7 Participants |
| Singleton delivery | 20 Participants | 10 Participants | 10 Participants |
| Type of Acid Reflux medication consumed Famotidine | 2 Participants | 1 Participants | 1 Participants |
| Type of Acid Reflux medication consumed Mylanta | 1 Participants | 0 Participants | 1 Participants |
| Type of Acid Reflux medication consumed None | 17 Participants | 9 Participants | 8 Participants |
| Type of allergy (father) Allergic rhinitis | 4 Participants | 2 Participants | 2 Participants |
| Type of allergy (father) Asthma | 2 Participants | 2 Participants | 0 Participants |
| Type of allergy (father) Eczema | 4 Participants | 3 Participants | 1 Participants |
| Type of allergy (father) Food allergy | 4 Participants | 3 Participants | 1 Participants |
| Type of allergy (father) None | 6 Participants | 0 Participants | 6 Participants |
| Type of allergy (mother) Allergic rhinitis | 2 Participants | 1 Participants | 1 Participants |
| Type of allergy (mother) Asthma | 0 Participants | 0 Participants | 0 Participants |
| Type of allergy (mother) Eczema | 4 Participants | 1 Participants | 3 Participants |
| Type of allergy (mother) Food allergy | 1 Participants | 0 Participants | 1 Participants |
| Type of allergy (mother) None | 13 Participants | 8 Participants | 5 Participants |
| Weight at birth | 3.37 kilograms (kg) STANDARD_DEVIATION 0.51 | 3.18 kilograms (kg) STANDARD_DEVIATION 0.527 | 3.56 kilograms (kg) STANDARD_DEVIATION 0.417 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 10 | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Changes to Gut Microbiome Composition
Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline).
Time frame: Baseline to Day 28
Population: There will be two analysis populations defined for this study. Analysis of the primary, key secondary, and other secondary endpoints will be completed on the modified Intent-to-Treat (mITT) population. All safety-related tabulations will be based upon the Safety population. The mITT population will include all infants who are randomized and receive at least one supplementation of the intervention. Infants will be analyzed according to the group to which they are randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INF108F | Changes to Gut Microbiome Composition | 42.816 Change in %B.infantis reads (Day 28-BL) | Standard Deviation 53.236 |
| Placebo | Changes to Gut Microbiome Composition | -12.413 Change in %B.infantis reads (Day 28-BL) | Standard Deviation 35.104 |
p-value: 0.154Wilcoxon range sum test
Secondary
Changes to Clinical Symptoms of FPIAP
We will collect information using questionnaires about infants' gastroesophageal reflux disease symptoms, feeding, sleep and stool frequency and consistency. The severity of infant GER will be quantified using the Infant Gastroesophageal Reflux Questionnaire (I-GERQ), with numeric scores. The minimum score is 0 and the maximum score is 25; scores \>7 provide 74% specificity and 94% sensitivity for diagnosing GERD. Higher I-GERQ scores/values are indicative of worse outcomes, worse reflux symptoms for the infant. The secondary outcome was reported as the absolute change from baseline in I-GERQ score; therefore, a higher value would be positive as the score is reduced significantly from baseline, which means reflux symptoms were improved. The sleep will be captured using Infant Sleep Questionnaire, with 0-10 scales, 0 means worst sleep and 10 means excellent sleep for quantify the quality of infant's night sleep.
Time frame: Baseline to day 28
Population: Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INF108F | Changes to Clinical Symptoms of FPIAP | -5.5 Scores on a scale |
| Placebo | Changes to Clinical Symptoms of FPIAP | 0.0 Scores on a scale |
p-value: 0.073Wilcoxon (Mann-Whitney)
Secondary
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
Time frame: Baseline, Study Day 7, Study Day 14, Study Day 28
Population: Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A moderate problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A small problem | 2 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A serious problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A very small problem | 1 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | Missing | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A moderate problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | Not a problem at all | 2 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | Missing | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A very small problem | 4 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A serious problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A small problem | 1 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A moderate problem | 3 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A moderate problem | 2 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | Missing | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A serious problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | Not a problem at all | 1 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | Missing | 1 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | Not a problem at all | 2 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | Not a problem at all | 3 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A small problem | 4 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A very small problem | 3 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A very small problem | 3 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A small problem | 2 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A very small problem | 7 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A moderate problem | 2 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A small problem | 5 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A serious problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A serious problem | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | Missing | 0 Participants |
| INF108F | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | Not a problem at all | 2 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | Missing | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | Not a problem at all | 5 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A very small problem | 3 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A small problem | 1 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A moderate problem | 1 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | A serious problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 0 (Baseline) | Missing | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | Not a problem at all | 6 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A very small problem | 3 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A small problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A moderate problem | 1 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | A serious problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 7 | Missing | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | Not a problem at all | 6 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A very small problem | 2 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A small problem | 1 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A moderate problem | 1 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | A serious problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 14 | Missing | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | Not a problem at all | 6 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A very small problem | 3 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A small problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A moderate problem | 1 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | A serious problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 21 | Missing | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | Not a problem at all | 6 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A very small problem | 2 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A small problem | 0 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A moderate problem | 2 Participants |
| Placebo | Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log | Day 28 | A serious problem | 0 Participants |
Comparison: Day 0 (Baseline)p-value: 0.057Cochran-Mantel-Haenszel
Comparison: Day 7p-value: 0.169Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.168Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.139Cochran-Mantel-Haenszel
Comparison: Day 28p-value: 0.348Cochran-Mantel-Haenszel
Secondary
Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log
Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
Time frame: Enrollment to Study Day 14
Population: Percentage of infants with no gross/visible blood in stool on Study Day 14 via the daily log
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| INF108F | Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log | Gross/visible blood in stool on Day 14 | 0 Participants |
| INF108F | Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log | No gross/visible blood in stool on Day 14 | 10 Participants |
| Placebo | Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log | Gross/visible blood in stool on Day 14 | 2 Participants |
| Placebo | Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log | No gross/visible blood in stool on Day 14 | 8 Participants |
p-value: 0.471Fisher Exact