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CompletedNCT01813175Updated Sep 7, 2017

Color Synbiotics Study

An interventional study of Regular non-hydrolysed cow's milk I and Regular non-hydrolysed cow's milk II in Beneficial Bacteria in Gut, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Completed at 3 sites in Thailand. Open to participants aged 43 Days to 65 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by Danone Asia Pacific Holdings Pte, Ltd. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
43 Days to 65 Days
Sex
All
01

Study summary

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

02

Conditions studied

  • Beneficial Bacteria in Gut
03

In context

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
43 Days to 65 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
290 participants (actual)

Study arms

  • 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

  • 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

  • Placebo comparator
    Control Group

    Regular non-hydrolysed cow's milk based infant formula

    Other: Regular non-hydrolysed cow's milk - control

  • No intervention
    Reference Group

    Exclusively breast-fed infants

Interventions

  • OtherRegular non-hydrolysed cow's milk I

    Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I

  • OtherRegular non-hydrolysed cow's milk II

    Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II

  • OtherRegular non-hydrolysed cow's milk - control

    Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture

06

What researchers measure

Primary outcomes

  1. Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group

    Time frame: baseline, week 6

Secondary outcomes

  1. Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group

    Time frame: baseline, week 6

  2. Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group

    Time frame: baseline, week 6

07

Study locations

3 sites
  • Thammasat Hospital
    Klong Luang, Pathumthani, Thailand
  • King Chulalongkorn Memorial Hospital
    Bangkok, Thailand
  • Phramongkutklao Hospital
    Bangkok, Thailand
08

References and documents

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. PubMed 33574421 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01813175
Lead sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Responsible party
Sponsor
First posted
Mar 18, 2013
Start date
May 2013
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Sep 7, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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