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

Phase 2

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Probaclac; Other: Placebo

• Registration Number: NCT00793494
• Lead Sponsor: St. Justine's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2009-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Children 8 to 18 years
• Irritable bowel syndrome according to Rome III criteria

Exclusion Criteria

• Not able to collaborate
• Known Digestive malformation
• History of digestive surgery (except hernia repair and appendectomy)
• History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease)
• Symptoms suggestive of organic disease (such as rectal bleeding, weight loss
• History of chronic extra-digestive disease
• Acute gastroenteritis in th e4 weeks prior to inclusion
• Central catheter, artificial cardiac valve, endocardiac prothesis
• Current Antidepressant treatment
• Patients taking a treatment for irritable bowel syndrome unable to cease their current treatment
• Patient taking regularly probiotics and natural products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probaclac	Probaclac	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™) b.i.d.
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Subjective assessment of improvement of symptoms	4 weeks

Secondary Outcome Measures

Name	Time	Method
Presence and intensity of pain episodes	4 weeks
Change in severity of symptoms (likert scale)	4 weeks
Presence or absence of urgency, incomplete evacuation, gas	4 weeks
Adverse Events	2 months
Number and consistance of the stools	4 weeks
Quality of Life	4 weeks
School and social absenteism	4 weeks

Trial Locations

Locations (1)

Hôpital Sainte Justine; 🇨🇦 Montreal, Quebec, Canada