CompletedNCT01861600Updated May 23, 2013

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

A Phase 3 interventional study of S-26 Gold and S-26 Gold EF1 in Stool Composition, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Philippines. Open to participants aged 7 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-23.

Sponsored by Société des Produits Nestlé (SPN) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 375
Allocation: Randomized
Ages: 7 Days to 14 Days
Sex: All

Study 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.

Read the 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.

Conditions studied

Stool Composition

Keywords

Stool composition

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 7 Days to 14 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 375 participants (actual)

Study arms

Experimental
Experimental (EF) 1
For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1
Other: S-26 Gold EF1
Active comparator
Standard Formula
For 8 weeks, infants will consume ad libitum per day. S-26 Gold
Other: S-26 Gold
Experimental
Experimental 2 (EF2) S-26 Gold
For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2
Other: S-26 Gold EF2
Other
Human milk (HM)
For 8 weeks, infants will consume ad libitum per day. Human Milk
Other: Human Milk
Experimental
Experimental formula (EF) 3
For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3
Other: S-26 Gold EF3

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

What researchers measure

Primary outcomes

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
Time frame: 8 weeks

Secondary outcomes

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.
Time frame: 8 weeks

Other outcomes

Safety evaluation
evaluation of adverse events
Time frame: 10 weeks
Growth evaluation
Anthropometric measurements
Time frame: 8 weeks

Study locations

1 site

Asian Hospital and Medical Center
Metro Manila, Alabang 1780, Philippines

References and documents

Publications

Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443. PubMed 24840511 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01861600
Lead sponsor: Société des Produits Nestlé (SPN)
Responsible party: Sponsor
First posted: May 23, 2013
Start date: Apr 2009
Primary completion: Aug 2009
Completion: Aug 2009
Last update: May 23, 2013

Study contacts

Maria Rosario Zeta Capeding, MD

principal investigator · JRF Health Center Complex, Muntinlupa City, Philippines

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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