Status:
COMPLETED
Color Synbiotics Study
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Conditions:
Beneficial Bacteria in Gut
Eligibility:
All Genders
43-65 years
Phase:
NA
Brief Summary
This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01813175
Start Date
May 1 2013
End Date
July 1 2016
Last Update
September 7 2017
Active Locations (3)
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1
Thammasat Hospital
Klong Luang, Changwat Pathum Thani, Thailand
2
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
3
Phramongkutklao Hospital
Bangkok, Thailand