Gastrointestinal Tolerance
Conditions
Brief summary
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
Interventions
OTHERInfant Formula supplemented with Oligosaccharides
sole source nutrition
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 42 Days
Healthy volunteers
Yes
Inclusion criteria
* Subject is in good health as determined from subject's medical history by parent report * Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks * Subject's birth weight was ≥ 2490 g (\ 5 lbs. 8 oz.) * Subject is between 7 and 42 days of age * Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation * Infant is exclusively formula-fed at time of study entry * Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study * Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study
Exclusion criteria
* An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development * Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance * Subject participates in another study that has not been approved as a concomitant study * Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment * Subject has been treated with oral antibiotics within 7 days prior to study enrollment * Mother intends to use a combination of breast and formula feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fussiness | Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1) | Parent Questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fussiness | Baseline to SDAY 29 | Parent Questionnaires |
| Hours of daily crying | Baseline to SDAY 29 | Parent Questionnaires |
| Gastrointestinal Tolerance | Baseline to SDAY 29 | Parent Questionnaires |
| Stool Pattern | Baseline to SDAY 29 | Parent Questionnaire |
Countries
United States
Outcome results
None listed