Overview

This trial is active, not recruiting.

Conditions infections, stool flora, stool biochemistry, constipation, food intolerance
Treatment new infant formula with prebiotics and beta-palmitate
Sponsor Waldkrankenhaus Protestant Hospital, Spandau
Start date August 2011
End date October 2014
Trial size 102 participants
Trial identifier NCT01603719, EWK-001

Summary

The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
Standard formula with no supplementation
(Experimental)
infant formula with higher beta-palmitate and supplemented GOS
new infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life

Primary Outcomes

Measure
number of gastrointestinal infections
time frame: within first year of life

Secondary Outcomes

Measure
proportion of bifidobacteria on total stool bacteria
time frame: after 6 and 12 weeks intervention
number of infectious episodes (gastrointestinal, respiratory, fever episodes)
time frame: within first year of life
anthropometric parameters (gain in weight, length, head circumference)
time frame: after 6 weeks, after 12 weeks intervention
symptoms of food intolerance, constipation, colics
time frame: after 6 weeks, 12 weeks intervention
stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)
time frame: after 6 weeks, 12 weeks intervention
atopic manifestation
time frame: within 1st year of life
erythrocytes´ fatty acid profile
time frame: after 6 weeks intervention
calcium absorption
time frame: after 6 weeks, 12 weeks intervention

Eligibility Criteria

Male or female participants up to 10 days old.

Inclusion Criteria: - healthy term neonates - gestational age 37 to 42 weeks - birth weight 10th to 90th percentile (Voigt reference) - infants being exclusively formula-fed at enrollment Exclusion Criteria: - infants with high risk of atopic disease due to family history - congenital disorder or syndrome with need for special diet / impairment of growth - antibiotic medication prior to enrollment

Additional Information

Official title Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life
Principal investigator Frank Jochum, MD
Description An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial. The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Waldkrankenhaus Protestant Hospital, Spandau.