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This study has been withdrawn prior to enrollment.
(The study was withdrawn due to change of the study product formulation.)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
  Purpose

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.


Condition Intervention Phase
Healthy Infants
Other: Regular non-hydrolysed cow's milk
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Danone Asia Pacific Holdings Pte, Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 II
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 the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
No Intervention: Reference group
Exclusively breast-fed infants

  Eligibility

Ages Eligible for Study:   8 Weeks to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507935

Locations
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
Danone Research
Investigators
Principal Investigator: Sungkom Jongpiputvanich, A/Prof., MD. Chulalongkorn University
  More Information

No publications provided

Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT01507935     History of Changes
Other Study ID Numbers: COL.1.C/A
Study First Received: January 5, 2012
Last Updated: September 4, 2012
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Danone Asia Pacific Holdings Pte, Ltd.:
Healthy infants
Infant formula
Prebiotics oligosaccharides
Colonisation Resistance
Gut Microbiota

ClinicalTrials.gov processed this record on April 17, 2014