Fiber Tolerability in Children (FITIC)

Assessment of the digestive tolerability of the PROMITOR® .

Study Overview

• Status: Completed
• Conditions: Signs and Symptoms, Digestive
• Intervention / Treatment: Drug: Placebo (including Maltodextrin); Drug: PROMITOR® (including Maltodextrin); Drug: PROMITOR® (including Maltodextrin); Drug: PROMITOR® (including Maltodextrin)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Herblain, France, 44800
    • Biofortis
• Switzerland
  • Lausanne, Switzerland, 1000
    • Metabolic Unit, Clinical Development Unit Nestec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (including Maltodextrin)
Active Comparator: PROMITOR® dose 1; Investigational product dose 1	Drug: PROMITOR® (including Maltodextrin); Investigational product dose 1; Drug: PROMITOR® (including Maltodextrin); Investigational product dose 2; Drug: PROMITOR® (including Maltodextrin); Investigational product dose 3
Active Comparator: PROMITOR® dose 2; Investigational product dose 2	Drug: PROMITOR® (including Maltodextrin); Investigational product dose 1; Drug: PROMITOR® (including Maltodextrin); Investigational product dose 2; Drug: PROMITOR® (including Maltodextrin); Investigational product dose 3
Active Comparator: PROMITOR® dose 3; Investigational product dose 3	Drug: PROMITOR® (including Maltodextrin); Investigational product dose 1; Drug: PROMITOR® (including Maltodextrin); Investigational product dose 2; Drug: PROMITOR® (including Maltodextrin); 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	7 days of intake
Assessment of the digestive tolerability of the Investigational Product (rumbling)	Using analog visual scale	7 days of intake
Assessment of the digestive tolerability of the Investigational Product (bloating)	Using analog visual scale	7 days of intake
Assessment of the digestive tolerability of the Investigational Product (flatulence)	Using analog visual scale	7 days of intake
Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency)	Using analog visual scale	7 days of intake

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Children; Fiber tolerability
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive
• Other Study ID Numbers: 14.29. NRC