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

NCT01861600 | Completed Phase 3

• 1 other identifier: 9055A1-3001
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Stool Composition

Keywords

Stool composition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  8 weeks

Other Outcomes (2)

• Safety evaluation

  10 weeks

• Growth evaluation

  8 weeks

Study Arms (5)

Experimental (EF) 1

EXPERIMENTAL

For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1

Other: S-26 Gold EF1

Standard Formula

ACTIVE COMPARATOR

For 8 weeks, infants will consume ad libitum per day. S-26 Gold

Other: S-26 Gold

Experimental 2 (EF2) S-26 Gold

EXPERIMENTAL

For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2

Other: S-26 Gold EF2

Human milk (HM)

OTHER

For 8 weeks, infants will consume ad libitum per day. Human Milk

Other: Human Milk

Experimental formula (EF) 3

EXPERIMENTAL

For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3

Other: S-26 Gold EF3

Interventions

S-26 Gold OTHER

(13.4 g/L protein) with 100% Fat Blend A

Standard Formula

S-26 Gold EF1 OTHER

(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend

Experimental (EF) 1

S-26 Gold EF2 OTHER

(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose

Experimental 2 (EF2) S-26 Gold

S-26 Gold EF3 OTHER

(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose

Experimental formula (EF) 3

Human Milk OTHER

Human Milk

Human milk (HM)

Eligibility Criteria

• Age: 7 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Asian Hospital and Medical Center

Metro Manila, Alabang, 1780, Philippines

Location

Related Publications (1)

• 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.

  PMID: 24840511 DERIVED

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Maria Rosario Zeta Capeding, MD

  JRF Health Center Complex, Muntinlupa City, Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

PH (1)