Stool Composition
Conditions
Keywords
Stool composition
Brief summary
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
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.
Interventions
OTHERS-26 Gold
(13.4 g/L protein) with 100% Fat Blend A
OTHERS-26 Gold EF1
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend
OTHERS-26 Gold EF2
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose
OTHERS-26 Gold EF3
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose
OTHERHuman Milk
Human Milk
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
1. 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 2. Weight for age ≥5th percentile according to Filipino growth tables/charts. 3. HM infants were exclusively consuming and tolerating HM 4. Mother must have made the decision to continue to exclusively breastfeed. 5. Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula 6. Parent/guardian must have previously made the decision to continue to exclusively formula feed
Exclusion criteria
1. Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa 2. Infants who are receiving any infant formula containing pro- or prebiotics 3. Family history of siblings with documented cow's milk protein intolerance/allergy 4. Conditions requiring infant feedings other than those specified in the protocol 5. Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation) 6. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus, cytomegalovirus) 7. Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases 8. 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 9. 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 10. 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 11. HM-fed infants whose mothers are presently receiving or have received any antibiotics or antifungal medications (except topical), post partum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas | 8 weeks | stool composition: stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas | 8 weeks | Determinations of fecal flora as well as fecal pH, sIgA concentrations and SCFA concentrations in a subset of subjects. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | 10 weeks | evaluation of adverse events |
| Growth evaluation | 8 weeks | Anthropometric measurements |
Countries
Philippines
Outcome results
None listed