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

Primary Purpose

Irritable Bowel Syndrome

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Probaclac
Placebo
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Children, Pediatrics, Probiotics

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Sainte Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probaclac

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Subjective assessment of improvement of symptoms

Secondary Outcome Measures

Change in severity of symptoms (likert scale)
Presence and intensity of pain episodes
Presence or absence of urgency, incomplete evacuation, gas
Number and consistance of the stools
School and social absenteism
Quality of Life
Adverse Events

Full Information

First Posted
November 17, 2008
Last Updated
April 12, 2016
Sponsor
St. Justine's Hospital
Collaborators
Nicar Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00793494
Brief Title
Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years
Acronym
POPSII
Official Title
Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment impossible
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Nicar Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, Children, Pediatrics, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probaclac
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Probaclac
Intervention Description
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™)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo composition matodextrin, gelatin, ascorbic acid, soya
Primary Outcome Measure Information:
Title
Subjective assessment of improvement of symptoms
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in severity of symptoms (likert scale)
Time Frame
4 weeks
Title
Presence and intensity of pain episodes
Time Frame
4 weeks
Title
Presence or absence of urgency, incomplete evacuation, gas
Time Frame
4 weeks
Title
Number and consistance of the stools
Time Frame
4 weeks
Title
School and social absenteism
Time Frame
4 weeks
Title
Quality of Life
Time Frame
4 weeks
Title
Adverse Events
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe M Faure, MD
Organizational Affiliation
Ste-Justine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.christophefaure.org
Description
Related Info

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

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