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

Nestlé

Status and phase: Completed; Phase 3

Conditions: Stool Composition

Treatments: Other: Human Milk; Other: S-26 Gold EF2; Other: S-26 Gold; Other: S-26 Gold EF1; Other: S-26 Gold EF3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01861600

9055A1-3001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 patients

Sex: All

Ages: 7 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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375 participants in 5 patient groups

Experimental (EF) 1

Experimental group

Description:

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

Treatment:

Other: S-26 Gold EF1

Standard Formula

Active Comparator group

Description:

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

Treatment:

Other: S-26 Gold

Experimental 2 (EF2) S-26 Gold

Experimental group

Description:

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

Treatment:

Other: S-26 Gold EF2

Human milk (HM)

Other group

Description:

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

Treatment:

Other: Human Milk

Experimental formula (EF) 3

Experimental group

Description:

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

Treatment:

Other: S-26 Gold EF3