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Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years

NCT00793494 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-04-13

No results posted yet for this study

Summary

The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo.

This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up.

4 visits and 4 phone calls are planned during the study.

Conditions

  • Irritable Bowel Syndrome

Interventions

OTHER

Probaclac

Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™)

OTHER

Placebo

Placebo composition matodextrin, gelatin, ascorbic acid, soya

Sponsors & Collaborators

  • Nicar Inc.

    collaborator INDUSTRY

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Christophe M Faure, MD · Ste-Justine Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793494 on ClinicalTrials.gov