Colonisation Resistance Study

NCT01507935 | Withdrawn Phase 2

• 1 other identifier: COL.1.C/A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Infants

Keywords

Healthy infants; Infant formula; Prebiotics oligosaccharides; Colonisation Resistance; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• Gut microbiota composition and its metabolic activity

  * 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 Outcomes (3)

• Gastrointestinal symptoms (incidence and severity)

  Week 1, Week 3, Week 6, Week 8

• Anthropometry

  Week 1, Week 3, Week 6, Week 8

• Number, type and severity of (serious) adverse events

  Week 1, Week 3, Week 6, Week 8

Study Arms (4)

Intervention Group I

ACTIVE COMPARATOR

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

Intervention Group II

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Reference group

NO INTERVENTION

Exclusively breast-fed infants

Interventions

Regular non-hydrolysed cow's milk OTHER

Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I

Intervention Group I

Eligibility Criteria

• Age: 8 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (2)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

Study Officials

• Sungkom Jongpiputvanich, A/Prof., MD.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

TH (2)