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Colonisation Resistance Study (ColoR)

This study has been withdrawn prior to enrollment.
(The study was withdrawn due to change of the study product formulation.)
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier:
NCT01507935
First received: January 5, 2012
Last updated: September 4, 2012
Last verified: September 2012
History of Changes

January 5, 2012
September 4, 2012
January 2012
November 2012   (final data collection date for primary outcome measure)
Gut microbiota composition and its metabolic activity [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • 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
Same as current
Complete list of historical versions of study NCT01507935 on ClinicalTrials.gov Archive Site
  • Gastrointestinal symptoms (incidence and severity) [ Time Frame: Week 1, Week 3, Week 6, Week 8 ] [ Designated as safety issue: Yes ]
  • Anthropometry [ Time Frame: Week 1, Week 3, Week 6, Week 8 ] [ Designated as safety issue: Yes ]
  • Number, type and severity of (serious) adverse events [ Time Frame: Week 1, Week 3, Week 6, Week 8 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Colonisation Resistance Study
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy Infants
  • 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 I
    Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I
    Intervention: Other: Regular non-hydrolysed cow's milk
  • Active Comparator: Intervention Group II
    Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II
    Intervention: Other: Regular non-hydrolysed cow's milk
  • 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
    Intervention: Other: Regular non-hydrolysed cow's milk
  • No Intervention: Reference group
    Exclusively breast-fed infants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
8 Weeks to 10 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01507935
COL.1.C/A
No
Danone Asia Pacific Holdings Pte, Ltd.
Danone Asia Pacific Holdings Pte, Ltd.
Danone Research
Principal Investigator: Sungkom Jongpiputvanich, A/Prof., MD. Chulalongkorn University
Danone Asia Pacific Holdings Pte, Ltd.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP