Status:
TERMINATED
Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Nicar Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
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 bulgari...
Eligibility Criteria
Inclusion
- Children 8 to 18 years
- Irritable bowel syndrome according to Rome III criteria
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00793494
Start Date
January 1 2009
End Date
May 1 2015
Last Update
April 13 2016
Active Locations (1)
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1
Hôpital Sainte Justine
Montreal, Quebec, Canada, H3T1C5