Fiber Tolerability in Children Aged 3-7 Year (Fiber - TIC)

Fiber Tolerability In Children Aged 3-7 Year

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

Study Overview

• Status: Completed
• Conditions: Signs and Symptoms, Digestive
• Intervention / Treatment: Drug: Placebo (including Maltodextrin); Drug: Dose 1 - Promitor®; Drug: Dose 2 - Promitor®; Drug: Dose 3 - Promitor®

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Herblain, France, 44800
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo (including Maltodextrin)
ACTIVE_COMPARATOR: Dose 1 - Promitor®; Investigational product Dose 1	Drug: Dose 1 - Promitor®
ACTIVE_COMPARATOR: Dose 2 - Promitor®; Investigational product Dose 2	Drug: Dose 2 - Promitor®
ACTIVE_COMPARATOR: Dose 3 - Promitor®; Investigational product Dose 3	Drug: Dose 3 - Promitor®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (ESTIMATE): February 9, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Children; Fiber tolerability
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive
• Other Study ID Numbers: 15.10.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO