Clinical trial NCT00793494: Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years
Official title: Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Children
Pediatrics
Probiotics
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Nicar Inc.
First posted: 2008-11-19
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective assessment of improvement of symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in severity of symptoms (likert scale)
timeFrame: 4 weeks
measure: Presence and intensity of pain episodes
timeFrame: 4 weeks
measure: Presence or absence of urgency, incomplete evacuation, gas
timeFrame: 4 weeks
measure: Number and consistance of the stools
timeFrame: 4 weeks
measure: School and social absenteism
timeFrame: 4 weeks
measure: Quality of Life
timeFrame: 4 weeks
measure: Adverse Events
timeFrame: 2 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Sainte Justine
state: Quebec
Study officials:
affiliation: Ste-Justine Hospital
name: Christophe M Faure, MD
role: PRINCIPAL_INVESTIGATOR
References: