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

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ClinicalTrials.gov Identifier: NCT00793494
Recruitment Status : Terminated (Recruitment impossible)
First Posted : November 19, 2008
Last Update Posted : April 13, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Probaclac Other: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2009
Primary Completion Date : May 2015
Study Completion Date : May 2015
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Subjective assessment of improvement of symptoms [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change in severity of symptoms (likert scale) [ Time Frame: 4 weeks ]
  2. Presence and intensity of pain episodes [ Time Frame: 4 weeks ]
  3. Presence or absence of urgency, incomplete evacuation, gas [ Time Frame: 4 weeks ]
  4. Number and consistance of the stools [ Time Frame: 4 weeks ]
  5. School and social absenteism [ Time Frame: 4 weeks ]
  6. Quality of Life [ Time Frame: 4 weeks ]
  7. Adverse Events [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793494


Locations
Canada, Quebec
Hôpital Sainte Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Nicar Inc.
Investigators
Principal Investigator: Christophe M Faure, MD Ste-Justine Hospital
More Information

Additional Information:
Responsible Party: Christophe Faure, MD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00793494     History of Changes
Other Study ID Numbers: Probaclac-HSJ
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

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

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