Fiber Tolerability in Children Aged 3-7 Year

Study Overview
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Brief Summary
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Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.

Detailed Description
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The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old. As it is an exploratory study there is no categorization between primary and secondary objectives.

Official Title
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Fiber Tolerability In Children Aged 3-7 Year

Conditions
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Signs and Symptoms, Digestive

Intervention / Treatment
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* Drug: Placebo (including Maltodextrin)
* Drug: Dose 1 - Promitor®
* Drug: Dose 2 - Promitor®
* Drug: Dose 3 - Promitor®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children Aged between 3 and 7 years old Acceptance of the taste of the product Having breakfast on daily basis Consent and/or assent received according to regulation Informed consent of both parents/guardians (in respect with the French regulation) Parents/guardians affiliated to a health insurance (in respect with the French regulation) Exclusion Criteria: Specific food regimen Intolerability or food allergy Antibiotic or any medication impacting the gut transit during the 2 weeks before the study Chronic gastrointestinal disease Gastroenteritis in the 2 weeks preceding the study Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week) Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking) Child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance Having participated in another clinical trial for 1 month, or currently participating in a clinical trial Under legal protection or deprived from his rights following administrative or judicial decision (in respect with the French regulation)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo (including Maltodextrin)<br> <br> |
| Active Comparator: Dose 1 - Promitor®<br>Investigational product Dose 1 | Drug: Dose 1 - Promitor®<br> <br> |
| Active Comparator: Dose 2 - Promitor®<br>Investigational product Dose 2 | Drug: Dose 2 - Promitor®<br> <br> |
| Active Comparator: Dose 3 - Promitor®<br>Investigational product Dose 3 | Drug: Dose 3 - Promitor®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale | Using analog visual scale | 7 days of intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiber tolerability, Children