Color Synbiotics Study

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

This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.

Study Overview

• Status: Completed
• Conditions: Beneficial Bacteria in Gut
• Intervention / Treatment: Other: Regular non-hydrolysed cow's milk I; Other: Regular non-hydrolysed cow's milk II; Other: Regular non-hydrolysed cow's milk - control

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand
    • Phramongkutklao Hospital
  • Pathumthani
    • Klong Luang, Pathumthani, Thailand
      • Thammasat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study
• 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 legal guardian's written informed consent

Exclusion Criteria:

• Exclusion criteria for run-in period (visit 1, screening) are:
• Being weaned before inclusion (introduction of any other foods other than formula or human milk)
• Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
• Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required
• Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
• Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks prior to entry into the study
• Received Inactivated Poliovirus Vaccine (IPV) or Rotavirus Vaccine (RV) prior to entry into the study
• Gastroenteritis or diarrhoea in the last two weeks prior to entry into the study
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group I; Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I	Other: Regular non-hydrolysed cow's milk I; Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
Active Comparator: Interventional Group II; Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II	Other: Regular non-hydrolysed cow's milk II; Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
Placebo Comparator: Control Group; Regular non-hydrolysed cow's milk based infant formula	Other: Regular non-hydrolysed cow's milk - control; Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture
No Intervention: Reference Group; Exclusively breast-fed infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group	baseline, week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group	baseline, week 6
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group	baseline, week 6

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Publications and helpful links

General Publications

• Phavichitr N, Wang S, Chomto S, Tantibhaedhyangkul R, Kakourou A, Intarakhao S, Jongpiputvanich S; COLOR Study Group; Roeselers G, Knol J. Impact of synbiotics on gut microbiota during early life: a randomized, double-blind study. Sci Rep. 2021 Feb 11;11(1):3534. doi: 10.1038/s41598-021-83009-2.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COL.1.C.A