Happy Smooth Study
Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Muntinlupa, Philippines, 1781
- Asian Hospital and Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Infant Formula
Experimental Infant Formula with a new fat blend plus L. reuteri
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Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum
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Active Comparator: Standard Infant Formula
Standard bovine milk-based infant formula.
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Standard bovine milk-based infant formula, fed ad libitum
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stool Consistency Score
Time Frame: Study Day 57, corresponding to infant age of 78-85 days
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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GI Tolerance
Time Frame: which corresponds to infant age of 21-28, 43-50, and 78-85 days.
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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.
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Changes in Weight from baseline to 57 days
Time Frame: Study Day 57, corresponding to infant age of 78-85 days
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weight (kg)
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Study Day 57, corresponding to infant age of 78-85 days
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Changes in Length from baseline to 57 days
Time Frame: Study Day 57, corresponding to infant age of 78-85 days
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length (cm)
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Study Day 57, corresponding to infant age of 78-85 days
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Changes in Head Circumference from baseline to 57 days
Time Frame: Study Day 57, corresponding to infant age of 78-85 days
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head circumference (cm)
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Study Day 57, corresponding to infant age of 78-85 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Elvira M Estorninos, University of Alberta
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16.28.INF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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