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

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.

Study Overview

• Status: Completed
• Conditions: Stool Composition
• Intervention / Treatment: Other: S-26 Gold EF1; Other: S-26 Gold; Other: S-26 Gold EF2; Other: Human Milk; Other: S-26 Gold EF3

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.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental (EF) 1; For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1	Other: S-26 Gold EF1; (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend
ACTIVE_COMPARATOR: Standard Formula; For 8 weeks, infants will consume ad libitum per day. S-26 Gold	Other: S-26 Gold; (13.4 g/L protein) with 100% Fat Blend A
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; (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose
OTHER: Human milk (HM); For 8 weeks, infants will consume ad libitum per day. Human Milk	Other: Human Milk; 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; (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	evaluation of adverse events	10 weeks
Growth evaluation	Anthropometric measurements	8 weeks

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Maria Rosario Zeta Capeding, MD, JRF Health Center Complex, Muntinlupa City, Philippines

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (ESTIMATE): May 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 23, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Stool composition
• Other Study ID Numbers: 9055A1-3001