Colonisation Resistance Study

Healthy Infants Clinical Trial

— ColoR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01507935
• Other study ID #: COL.1.C/A
• Status: Withdrawn
• Phase: Phase 2
• First received: January 5, 2012
• Last updated: September 4, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2012
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Weeks to 10 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
• Regular non-hydrolysed cow's milk
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
• 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

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	Danone Research

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Gastrointestinal symptoms (incidence and severity)		Week 1, Week 3, Week 6, Week 8	Yes
Secondary	Anthropometry		Week 1, Week 3, Week 6, Week 8	Yes
Secondary	Number, type and severity of (serious) adverse events		Week 1, Week 3, Week 6, Week 8	Yes