NCT02677090

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 29, 2016

Last Update Submit

March 9, 2016

Conditions

Signs and Symptoms, Digestive

Keywords

Fiber tolerabilityChildren

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo (including Maltodextrin)

Dose 1 - Promitor®

ACTIVE COMPARATOR

Investigational product Dose 1

Drug: Dose 1 - Promitor®

Dose 2 - Promitor®

ACTIVE COMPARATOR

Investigational product Dose 2

Drug: Dose 2 - Promitor®

Dose 3 - Promitor®

ACTIVE COMPARATOR

Investigational product Dose 3

Drug: Dose 3 - Promitor®

Interventions

Placebo (including Maltodextrin)DRUG
Placebo
Dose 1 - Promitor®DRUG
Dose 1 - Promitor®
Dose 2 - Promitor®DRUG
Dose 2 - Promitor®
Dose 3 - Promitor®DRUG
Dose 3 - Promitor®

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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 (in respect with the French regulation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Saint-Herblain, 44800, France

Location

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 9, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)