NCT00793494

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

6.3 years

First QC Date

November 17, 2008

Last Update Submit

April 12, 2016

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndromeChildrenPediatricsProbiotics

Outcome Measures

Primary Outcomes (1)

  • Subjective assessment of improvement of symptoms

    4 weeks

Secondary Outcomes (7)

  • Change in severity of symptoms (likert scale)

    4 weeks

  • Presence and intensity of pain episodes

    4 weeks

  • Presence or absence of urgency, incomplete evacuation, gas

    4 weeks

  • Number and consistance of the stools

    4 weeks

  • School and social absenteism

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Probaclac

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ProbaclacOTHER

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™)

Probaclac
PlaceboOTHER

Placebo composition matodextrin, gelatin, ascorbic acid, soya

Placebo

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children 8 to 18 years
  • Irritable bowel syndrome according to Rome III criteria

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Sainte Justine

Montreal, Quebec, H3T1C5, Canada

Location

Related Links

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Christophe M Faure, MD

    Ste-Justine Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

January 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

CA(1)