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
Name Time Method 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
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms do synbiotics in NCT01813175 infant formula use to modulate Bifidobacterium and Lactobacillus populations?
How does Danone's synbiotic infant formula compare to standard non-hydrolysed cow's milk in promoting beneficial gut microbiota composition?
Which gut microbiota biomarkers predict response to synbiotic supplementation in NCT01813175 healthy infants?
What adverse events were reported in NCT01813175 and how were they managed in synbiotic-treated infants?
Are there combination approaches with Danone's synbiotics and other prebiotics/probiotics for infant gut health?
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