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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This study has been withdrawn prior to enrollment.
(The study was withdrawn due to change of the study product formulation.)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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014