Colonisation Resistance Study

Study Overview
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Brief Summary
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This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.

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

Conditions
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Healthy Infants

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion 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 guardian's written informed consent Exclusion Criteria: Being weaned before inclusion (introduction of any other foods other than formula or breast milk.) Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps) Significant congenital abnormality that could affect the study results Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study Gastroenteritis in the last two weeks before inclusion

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 10 Weeks

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group I<br>Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I | Other: Regular non-hydrolysed cow's milk<br>* Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I<br>|
| Active Comparator: Intervention Group II<br>Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II | Other: Regular non-hydrolysed cow's milk<br>* Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II<br>|
| Placebo Comparator: Control Group<br>Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides | Other: Regular non-hydrolysed cow's milk<br>* Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides<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 |
| --- | --- | --- |
| Gut microbiota composition and its metabolic activity | Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut Metabolic activity of the gut microbiota: pH, SCFA, lactate | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms (incidence and severity) |  | Week 1, Week 3, Week 6, Week 8 | 
| Anthropometry |  | Week 1, Week 3, Week 6, Week 8 | 
| Number, type and severity of (serious) adverse events |  | Week 1, Week 3, Week 6, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy infants, Infant formula, Prebiotics oligosaccharides, Colonisation Resistance, Gut Microbiota