Gastro-Intestinal Tolerance
Conditions
Brief summary
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
Interventions
OTHERStudy Infant Formula
RTF milk-based infant formula with oligosaccharides
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 65 Days
Healthy volunteers
Yes
Inclusion criteria
* Participant is judged to be in good health as determined from participant's medical history by parent report * Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks. * Participant's birth weight was \>= 2490 g (\ 5 lbs. 8 oz.) * Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed * Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional. * Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study * Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study
Exclusion criteria
* An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse. * Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance. * Participant participates in another study that has not been approved as a concomitant study * Participant has been fed a formula with greater than 2 HMOs prior to study enrollment * Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician. * Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent * Participant has been treated with antibiotics within 7 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fussiness | Baseline to Study Day (SDAY) 2 | Absolute and % change in fussiness severity reported from Daily Tolerance Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Baseline to SDAY 28 | Parent Completed Diary |
| Stool | Baseline to SDAY 28 | Parent Completed Diary |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length | SDAY 1 to SDAY 28 | Length gains, percentiles, and z-scores |
| Infant Feeding and Stool Patterns Questionnaire | SDAY 1 and SDAY 28 | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent |
| Adverse Events | SDAY 1 to SDAY 28 | Standard adverse event reporting |
| Parental perspectives | SDAY 1 and SDAY 28 | Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive |
| Health Resource Utilization | SDAY 7 and SDAY 28 | Number of Visits |
| Formula Satisfaction Questionnaire | SDAY 1 and SDAY 28 | Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative |
| Formula Intake | SDAY 1 to SDAY 28 | Parent Completed Diary |
| Weight | SDAY 1 to SDAY 28 | Weight gains, percentiles, and z-scores |
Countries
United States
Outcome results
None listed