Color Synbiotics Study

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

Official Title
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Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.

Conditions
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Beneficial Bacteria in Gut

Intervention / Treatment
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* Other: Regular non-hydrolysed cow's milk I
* Other: Regular non-hydrolysed cow's milk II
* Other: Regular non-hydrolysed cow's milk - control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 43 Days
Maximum Age: 65 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group I<br>Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I | Other: Regular non-hydrolysed cow's milk I<br>* Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I<br>|
| Active Comparator: Interventional Group II<br>Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II | Other: Regular non-hydrolysed cow's milk II<br>* Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II<br>|
| Placebo Comparator: Control Group<br>Regular non-hydrolysed cow's milk based infant formula | Other: Regular non-hydrolysed cow's milk - control<br>* Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture<br>|
| No Intervention: Reference Group<br>Exclusively breast-fed infants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |