Gastrointestinal Tolerance
Conditions
Brief summary
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
Interventions
OTHERInfant formula supplemented with prebiotics
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 judged to be in good health. * Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks. * Subject's birth weight was ≥ 2490 g (\ 5 lbs. 8 oz.). * Infant was identified by parents as very fussy or extremely fussy. * Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. * 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.
Exclusion criteria
* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. * Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect 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 study day 1) to within 1 day of initiation of study feeding | Parent questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fussiness | Baseline to Day 29 | Parent Questionnaires |
| Hours of Daily Crying | Baseline to Day 29 | Parent Questionnaires |
| Gastrointestinal Tolerance | Baseline to Day 29 | Parent Questionnaires |
| Stool Pattern | Baseline to Day 29 | Parent Questionnaires |
Countries
United States
Outcome results
None listed