Colonisation Resistance Study

Phase 2

Withdrawn

• Conditions: Healthy Infants
• Interventions: Other: Regular non-hydrolysed cow's milk

• Registration Number: NCT01507935
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-08
• Study First Posted: 2012-01-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group I	Regular non-hydrolysed cow's milk	Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I
Intervention Group II	Regular non-hydrolysed cow's milk	Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II
Control Group	Regular non-hydrolysed cow's milk	Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition and its metabolic activity	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand