Clinical trial NCT01813175: Color Synbiotics Study
Official title: Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beneficial Bacteria in Gut
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 290
Sex: ALL
Minimum age (years): 43
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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

Primary outcomes:
measure: Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group
timeFrame: baseline, week 6
Secondary outcomes:
measure: Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group
timeFrame: baseline, week 6
measure: Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group
timeFrame: baseline, week 6
Other outcomes:
Locations:
city: Klong Luang
country: Thailand
facility: Thammasat Hospital
state: Pathumthani
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
References:
citation: 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.