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

NCT ID: NCT01861600

Last Updated: 2013-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

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.

Conditions

Stool Composition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental (EF) 1

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

Group Type: EXPERIMENTAL

S-26 Gold EF1

Intervention Type: OTHER

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

Standard Formula

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

Group Type: ACTIVE_COMPARATOR

S-26 Gold

Intervention Type: OTHER

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

Experimental 2 (EF2) S-26 Gold

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

Group Type: EXPERIMENTAL

S-26 Gold EF2

Intervention Type: OTHER

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

Human milk (HM)

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

Group Type: OTHER

Human Milk

Intervention Type: OTHER

Human Milk

Experimental formula (EF) 3

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

Group Type: EXPERIMENTAL

S-26 Gold EF3

Intervention Type: OTHER

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

Interventions

S-26 Gold

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

Intervention Type: OTHER

S-26 Gold EF1

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Human Milk

Human Milk

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Rosario Zeta Capeding, MD

Role: PRINCIPAL_INVESTIGATOR

JRF Health Center Complex, Muntinlupa City, Philippines

Locations

Asian Hospital and Medical Center

Metro Manila, Alabang, Philippines

Countries

Philippines

References

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.

Reference Type: DERIVED

PMID: 24840511 (View on PubMed)

Other Identifiers

9055A1-3001

Identifier Type: -

Identifier Source: org_study_id