Fiber Tolerability in Children Aged 3-7 Year

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

Brief Summary

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

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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.

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

Dose 1 - Promitor®

Investigational product Dose 1

Group Type ACTIVE_COMPARATOR

Dose 1 - Promitor®

Intervention Type DRUG

Dose 2 - Promitor®

Investigational product Dose 2

Group Type ACTIVE_COMPARATOR

Dose 2 - Promitor®

Intervention Type DRUG

Dose 3 - Promitor®

Investigational product Dose 3

Group Type ACTIVE_COMPARATOR

Dose 3 - Promitor®

Intervention Type DRUG

Interventions

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Placebo (including Maltodextrin)

Intervention Type DRUG

Dose 1 - Promitor®

Intervention Type DRUG

Dose 2 - Promitor®

Intervention Type DRUG

Dose 3 - Promitor®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy children
2. Aged between 3 and 7 years old
3. Acceptance of the taste of the product
4. Having breakfast on daily basis
5. Consent and/or assent received according to regulation
6. Informed consent of both parents/guardians (in respect with the French regulation)
7. Parents/guardians affiliated to a health insurance (in respect with the French regulation)

Exclusion Criteria

1. Specific food regimen
2. Intolerability or food allergy
3. Antibiotic or any medication impacting the gut transit during the 2 weeks before the study
4. Chronic gastrointestinal disease
5. Gastroenteritis in the 2 weeks preceding the study
6. Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week)
7. Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking)
8. 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
9. Having participated in another clinical trial for 1 month, or currently participating in a clinical trial
10. Under legal protection or deprived from his rights following administrative or judicial decision (in respect with the French regulation)

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes