Happy Smooth Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Detailed Description
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Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Official Title
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Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial

Conditions
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Infant Term Birth

Intervention / Treatment
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* Other: Experimental Infant Formula
* Other: Standard Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent Infants whose parents/LAR have reached the legal age of majority in the Philippines Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study Healthy term, singleton infant at birth Between 21 to 28 days post-natal age at enrollment visit Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment Exclusion Criteria: Infants with conditions requiring infant feedings other than those specified in the protocol Infants receiving complementary foods or liquids Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results

Ages Eligible for Study
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Minimum Age: 21 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Infant Formula<br>Experimental Infant Formula with a new fat blend plus L. reuteri | Other: Experimental Infant Formula<br>* Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum<br>|
| Active Comparator: Standard Infant Formula<br>Standard bovine milk-based infant formula. | Other: Standard Infant Formula<br>* Standard bovine milk-based infant formula, fed ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Consistency Score | 3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days. A validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools. Stool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate. the percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period. | Study Day 57, corresponding to infant age of 78-85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI Tolerance | Infant Gastrointestinal Symptom Questionnaire (IGSQ) Overall GI symptom burden will be measured with the IGSQ-13 questionnaire. The IGSQ-13 is an interviewer-administered questionnaire which measures how well the infant tolerates his/her feedings from the parent's/caregiver's perspective. The questionnaire is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fuzziness, and flatulence and summed to calculate an index score. | which corresponds to infant age of 21-28, 43-50, and 78-85 days. | 
| Changes in Weight from baseline to 57 days | weight (kg) | Study Day 57, corresponding to infant age of 78-85 days | 
| Changes in Length from baseline to 57 days | length (cm) | Study Day 57, corresponding to infant age of 78-85 days | 
| Changes in Head Circumference from baseline to 57 days | head circumference (cm) | Study Day 57, corresponding to infant age of 78-85 days |