Fiber Tolerability in Children Aged 3-7 Year

Not Applicable

Completed

• Conditions: Signs and Symptoms, Digestive
• Interventions: Drug: Placebo (including Maltodextrin); Drug: Dose 1 - Promitor®; Drug: Dose 2 - Promitor®; Drug: Dose 3 - Promitor®

• Registration Number: NCT02677090
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (including Maltodextrin)	Placebo
Dose 1 - Promitor®	Dose 1 - Promitor®	Investigational product Dose 1
Dose 2 - Promitor®	Dose 2 - Promitor®	Investigational product Dose 2
Dose 3 - Promitor®	Dose 3 - Promitor®	Investigational product Dose 3

Primary Outcome Measures

Name	Time	Method
Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale	7 days of intake	Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale	7 days of intake	Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale	7 days of intake	Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale	7 days of intake	Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale	7 days of intake	Using analog visual scale

Trial Locations

Locations (1)

Biofortis; 🇫🇷 Saint Herblain, France