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

March 9, 2016 updated by: Nestlé

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Herblain, France, 44800
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
ACTIVE_COMPARATOR: Dose 1 - Promitor®
Investigational product Dose 1
ACTIVE_COMPARATOR: Dose 2 - Promitor®
Investigational product Dose 2
ACTIVE_COMPARATOR: Dose 3 - Promitor®
Investigational product Dose 3

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.10.NRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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