Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants

Danone Asia Pacific Holdings Pte, Ltd.2 sites in 1 countryJanuary 2012

ConditionsHealthy Infants

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Healthy Infants
Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Locations: 2
Primary Endpoint: Gut microbiota composition and its metabolic activity
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
•Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
•Parents' or guardian's written informed consent

Exclusion Criteria

•Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
•Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
•Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
•Significant congenital abnormality that could affect the study results
•Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
•Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
•Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
•Gastroenteritis in the last two weeks before inclusion

Outcomes

Primary Outcomes

Gut microbiota composition and its metabolic activity

Time Frame: Week 6

* Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut * Metabolic activity of the gut microbiota: pH, SCFA, lactate

Secondary Outcomes

Number, type and severity of (serious) adverse events(Week 1, Week 3, Week 6, Week 8)
Gastrointestinal symptoms (incidence and severity)(Week 1, Week 3, Week 6, Week 8)
Anthropometry(Week 1, Week 3, Week 6, Week 8)