Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery

Study Overview
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Brief Summary
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The primary objectives of this trial are: to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product to investigate whether there is equivalence in growth between the four different groups of infant described above.

Detailed Description
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The primary objectives of this trial are: to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product to investigate whether there is equivalence in growth between the four different groups of infant described above. Design: This is a controlled, double blind, randomized, multi center, clinical trial of 4 groups in parallel. Two groups of infants (born from normal or caesarean delivery) will each consume one of 2 milk formulae. Number of patients (to be enrolled / to be analyzed): Approximately 450 / 240 Stratification will be done by gender and delivery mode. Description of subjects and main criteria for inclusion: Healthy full term infants born from HIV positive mothers who have elected to feed their child exclusively with a milk formula from birth. Children born after normal or caesarean delivery will be considered separately.

Official Title
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Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery

Conditions
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Healthy Full Term Infants

Intervention / Treatment
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* Dietary Supplement: formula with synbiotics
* Dietary Supplement: formula without synbiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborn infant from HIV positive mother Full term infant (more or equal to 37 weeks gestation; less or equal to 42 weeks gestation) Age of infant 3 days at the time of enrollment Birth weight between 2500 and 4500 grams Singleton birth The infant's mother has elected to feed their child exclusively with a milk formula from birth Informed consent from the parent or legal guardian Exclusion Criteria: Congenital illness or malformation that may affect normal growth Significant pre-natal and / or post-natal disease Newborns who have received antibiotics during the first 3 days of life Newborns whose parents / caregivers cannot be expected to comply with the study protocol Newborns currently participating in another clinical trial

Ages Eligible for Study
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Maximum Age: 3 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant starter formula with synbiotics<br>Infant starter formula with synbiotics | Dietary Supplement: formula with synbiotics<br> <br> |
| Active Comparator: Infant formula without synbiotics<br>Infant formula without synbiotics | Dietary Supplement: formula without synbiotics<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product |  | 3 days, 10 days, 1 month, and 3 months of age of the infant | 
| • Mean weight gain (g/day) |  | over 112 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition by DEXA |  | 4 month and 12 month of life | 
| Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) |  | 10 days, 1 month, 6 weeks, 3 month and 4 month of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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starter formula, stool microbiota, infants, caesarean section delivery