Colic, Inflammation
Conditions
Keywords
Lactobacillus, Probiotic, Crying time, Fecal microbiota, Calprotectin, Colic, Infant Crying, Barr Diary, Breath Hydrogen, Clinical Design
Brief summary
This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.
Interventions
DIETARY_SUPPLEMENTNutramigen with Enflora
Hypoallergenic formula with probiotic - Lactobacillus GG
DIETARY_SUPPLEMENTNutramigen A+
Hypoallergenic formula without lactobacillus
Sponsors
Mead Johnson Nutrition
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)
Exclusion criteria
* chronic lung disease, * diarrhea (stools that take the shape of a container \> 5x daily) * fever
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Average Crying and Fussing Duration According to Barr Diary Records | 90 days | The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Microbiota | 90 days | Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups. |
| Fecal Calprotectin | 90 days | Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nutramigen Lipil With Enflora Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG | 9 |
| Nutramigen A+ Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Nutramigen Lipil With Enflora | Nutramigen A+ | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 6 Participants | 7 Participants | 13 Participants |
| Region of Enrollment United States | 9 participants | 11 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Daily Average Crying and Fussing Duration According to Barr Diary Records
The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.
Time frame: 90 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nutramigen Lipil With Enflora | Daily Average Crying and Fussing Duration According to Barr Diary Records | 111 minutes |
| Nutramigen A+ | Daily Average Crying and Fussing Duration According to Barr Diary Records | 133 minutes |
Secondary
Fecal Calprotectin
Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.
Time frame: 90 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nutramigen Lipil With Enflora | Fecal Calprotectin | Visit 2 - Day 14 | 226 µg/g (feces) |
| Nutramigen Lipil With Enflora | Fecal Calprotectin | Visit 1- Baseline | 285 µg/g (feces) |
| Nutramigen Lipil With Enflora | Fecal Calprotectin | Visit 3 - Day 42 | 229 µg/g (feces) |
| Nutramigen Lipil With Enflora | Fecal Calprotectin | Visit 4 - Day 90 | 211 µg/g (feces) |
| Nutramigen A+ | Fecal Calprotectin | Visit 4 - Day 90 | 332 µg/g (feces) |
| Nutramigen A+ | Fecal Calprotectin | Visit 3 - Day 42 | 250 µg/g (feces) |
| Nutramigen A+ | Fecal Calprotectin | Visit 1- Baseline | 294 µg/g (feces) |
| Nutramigen A+ | Fecal Calprotectin | Visit 2 - Day 14 | 305 µg/g (feces) |
Secondary
Fecal Microbiota
Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.
Time frame: 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nutramigen Lipil With Enflora | Fecal Microbiota | Visit 1 - Baseline | .946 Shannon's diversity index value | Standard Deviation 0.927 |
| Nutramigen Lipil With Enflora | Fecal Microbiota | Visit 2- Day 14 | 1.314 Shannon's diversity index value | Standard Deviation 0.789 |
| Nutramigen Lipil With Enflora | Fecal Microbiota | Visit 3 - Day 42 | 1.047 Shannon's diversity index value | Standard Deviation 0.35 |
| Nutramigen Lipil With Enflora | Fecal Microbiota | Visit 4 - Day 90 | .676 Shannon's diversity index value | Standard Deviation 0.444 |
| Nutramigen A+ | Fecal Microbiota | Visit 4 - Day 90 | .737 Shannon's diversity index value | Standard Deviation 0.409 |
| Nutramigen A+ | Fecal Microbiota | Visit 1 - Baseline | .991 Shannon's diversity index value | Standard Deviation 0.415 |
| Nutramigen A+ | Fecal Microbiota | Visit 3 - Day 42 | 1.161 Shannon's diversity index value | Standard Deviation 0.612 |
| Nutramigen A+ | Fecal Microbiota | Visit 2- Day 14 | .537 Shannon's diversity index value | Standard Deviation 0.289 |