Fiber Tolerability in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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Assessment of the digestive tolerability of the PROMITOR® .

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Detailed Description

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The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fibers) over one week of intake.

The total sample size is 40 healthy children from 8 to 12 years old, male and female.

Conditions

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Signs and Symptoms, Digestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo (including Maltodextrin)

Intervention Type DRUG

PROMITOR® dose 1

Investigational product dose 1

Group Type ACTIVE_COMPARATOR

PROMITOR® (including Maltodextrin)

Intervention Type DRUG

Investigational product dose 1

PROMITOR® dose 2

Investigational product dose 2

Group Type ACTIVE_COMPARATOR

PROMITOR® (including Maltodextrin)

Intervention Type DRUG

Investigational product dose 2

PROMITOR® dose 3

Investigational product dose 3

Group Type ACTIVE_COMPARATOR

PROMITOR® (including Maltodextrin)

Intervention Type DRUG

Investigational product dose 3

Interventions

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Placebo (including Maltodextrin)

Intervention Type DRUG

PROMITOR® (including Maltodextrin)

Investigational product dose 1

Intervention Type DRUG

PROMITOR® (including Maltodextrin)

Investigational product dose 2

Intervention Type DRUG

PROMITOR® (including Maltodextrin)

Investigational product dose 3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy children,
* Aged between 8 and 12 years old included
* Acceptance of the taste of the product
* Having breakfast on daily basis
* Consent and/or assent received according to regulation
* Informed consent of one of the parents/guardians (for the study to be conducted in Switzerland, in respect with the Swiss regulation) or Informed consent of both parents/guardians (for the study to be conducted in France, in respect with the French regulation)
* Parents/guardians affiliated to a health insurance (only for the study to be conducted in France, 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 (only for the study to be conducted in France, in respect with the French regulation)

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes