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

This study is currently recruiting participants.
Verified October 2011 by St. Justine's Hospital
Sponsor:
Collaborator:
Nicar Inc.
Information provided by (Responsible Party):
Christophe Faure, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00793494
First received: November 17, 2008
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
 Other: Probaclac
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Subjective assessment of improvement of symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in severity of symptoms (likert scale) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Presence and intensity of pain episodes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Presence or absence of urgency, incomplete evacuation, gas [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number and consistance of the stools [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • School and social absenteism [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: January 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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™)
Placebo Comparator: Placebo Other: Placebo
Placebo composition matodextrin, gelatin, ascorbic acid, soya

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793494

Contacts
Contact: Christophe M Faure, MD 514 345 4931 ext 6666 christophe.faure@umontreal.ca

Locations
Canada, Quebec
Hôpital Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Christophe M Faure, MD     514 345 4931 ext 6666     christophe.faure@umontreal.ca    
Contact: Renée Dicaire, RN     514 345 4931 ext 5074     renee.dicaire@recherche-ste-justine.qc.ca    
Principal Investigator: Christophe M Faure, MD            
Sponsors and Collaborators
St. Justine's Hospital
Nicar Inc.
Investigators
Principal Investigator: Christophe M Faure, MD Ste-Justine Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Christophe Faure, MD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00793494     History of Changes
Other Study ID Numbers: Probaclac-HSJ
Study First Received: November 17, 2008
Last Updated: October 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Irritable bowel syndrome
Children
Pediatrics
Probiotics

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013