MedPath

Color Synbiotics Study

Not Applicable
Completed
Conditions
Beneficial Bacteria in Gut
Registration Number
NCT01813175
Lead Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
290
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control groupbaseline, week 6
Secondary Outcome Measures
NameTimeMethod
Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control groupbaseline, week 6
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control groupbaseline, week 6

Trial Locations

Locations (3)

Thammasat Hospital

🇹🇭

Klong Luang, Pathumthani, Thailand

King Chulalongkorn Memorial Hospital

🇹🇭

Bangkok, Thailand

Phramongkutklao Hospital

🇹🇭

Bangkok, Thailand

Thammasat Hospital
🇹🇭Klong Luang, Pathumthani, Thailand

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