Status:
COMPLETED
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Stool Composition
Eligibility:
All Genders
7-14 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT01861600
Start Date
April 1 2009
End Date
August 1 2009
Last Update
May 23 2013
Active Locations (1)
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1
Asian Hospital and Medical Center
Metro Manila, Alabang, Philippines, 1780