Clinical trial NCT01861600: Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Official title: Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stool Composition
Keywords: Stool composition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 375
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas
timeFrame: 8 weeks
Secondary outcomes:
measure: Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
timeFrame: 8 weeks
Other outcomes:
measure: Safety evaluation
timeFrame: 10 weeks
measure: Growth evaluation
timeFrame: 8 weeks
Locations:
city: Metro Manila
country: Philippines
facility: Asian Hospital and Medical Center
state: Alabang
Study officials:
affiliation: JRF Health Center Complex, Muntinlupa City, Philippines
name: Maria Rosario Zeta Capeding, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.