Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas

Study Overview
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Brief Summary
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The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.

Detailed Description
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The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition and characteristics and to investigate the effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool softness and bacteria. Because some studies demonstrate the benefit of high concentrations of a non-digestible carbohydrate in the formula, we will study 2 concentrations of added oligofructose.

Official Title
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Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas

Conditions
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Stool Composition

Intervention / Treatment
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* Other: S-26 Gold
* Other: S-26 Gold EF1
* Other: S-26 Gold EF2
* Other: S-26 Gold EF3
* Other: Human Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, term (no less than 37 weeks, 0 days and no greater than 42 weeks, 0 days) singleton infants, between 7 days and 14 day post natal age Weight for age ≥5th percentile according to Filipino growth tables/charts. HM infants were exclusively consuming and tolerating HM Mother must have made the decision to continue to exclusively breastfeed. Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula Parent/guardian must have previously made the decision to continue to exclusively formula feed Exclusion Criteria: Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa Infants who are receiving any infant formula containing pro- or prebiotics Family history of siblings with documented cow's milk protein intolerance/allergy Conditions requiring infant feedings other than those specified in the protocol Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation) Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus, cytomegalovirus) Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases Infants who have received any experimental treatment, participated in any other clinical trial, or received any other investigational intervention unrelated to this trial, prior to enrollment Infants of any ancillary personnel connected with the study or the infants of first and second-degree relatives (parents, brothers, sisters, children, or grandchildren) of ancillary personnel Presently receiving or have received any medication(s) which are known or suspected to affect fat digestion, absorption and/or metabolism (e.g., pancreatic enzymes), any vitamin and/or mineral supplements which contain calcium, all antibiotics and antifungal medications (except topical), suppositories, bismuth-containing medications, herbal supplements, or medications which may neutralize or suppress gastric acid secretion HM-fed infants whose mothers are presently receiving or have received any antibiotics or antifungal medications (except topical), post partum

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 14 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental (EF) 1<br>For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1 | Other: S-26 Gold EF1<br>* (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend<br>|
| Active Comparator: Standard Formula<br>For 8 weeks, infants will consume ad libitum per day. S-26 Gold | Other: S-26 Gold<br>* (13.4 g/L protein) with 100% Fat Blend A<br>|
| Experimental: Experimental 2 (EF2) S-26 Gold<br>For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2 | Other: S-26 Gold EF2<br>* (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose<br>|
| Other: Human milk (HM)<br>For 8 weeks, infants will consume ad libitum per day. Human Milk | Other: Human Milk<br>* Human Milk<br>|
| Experimental: Experimental formula (EF) 3<br>For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3 | Other: S-26 Gold EF3<br>* (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas | stool composition: stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas | Determinations of fecal flora as well as fecal pH, sIgA concentrations and SCFA concentrations in a subset of subjects. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stool composition