Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years
NCT ID: NCT00793494
Last Updated: 2016-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
44 participants
INTERVENTIONAL
2009-01-31
2015-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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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.
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™)
Placebo
Placebo
Placebo composition matodextrin, gelatin, ascorbic acid, soya
Interventions
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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™)
Placebo
Placebo composition matodextrin, gelatin, ascorbic acid, soya
Eligibility Criteria
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Inclusion Criteria
* Irritable bowel syndrome according to Rome III criteria
Exclusion Criteria
* 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
8 Years
18 Years
ALL
No
Sponsors
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Nicar Inc.
INDUSTRY
St. Justine's Hospital
OTHER
Responsible Party
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Christophe Faure
MD
Principal Investigators
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Christophe M Faure, MD
Role: PRINCIPAL_INVESTIGATOR
Ste-Justine Hospital
Locations
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Hôpital Sainte Justine
Montreal, Quebec, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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Probaclac-HSJ
Identifier Type: -
Identifier Source: org_study_id
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