Colonisation Resistance Study (ColoR)

September 4, 2012 updated by: Danone Asia Pacific Holdings Pte, Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand
        • Phramongkutklao Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention Group I
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
ACTIVE_COMPARATOR: Intervention Group II
Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
PLACEBO_COMPARATOR: Control Group
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
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
Other: Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
NO_INTERVENTION: Reference group
Exclusively breast-fed infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Collaborators

Danone Research

Investigators

  • Principal Investigator: Sungkom Jongpiputvanich, A/Prof., MD., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 8, 2012

First Posted (ESTIMATE)

January 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COL.1.C/A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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