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

Irritable Bowel Syndrome Clinical Trial

— POPSII  

Official title:

Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00793494
• Other study ID #: Probaclac-HSJ
• Status: Terminated
• Phase: Phase 2
• First received: November 17, 2008
• Last updated: April 12, 2016
• Start date: January 2009
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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
Placebo composition matodextrin, gelatin, ascorbic acid, soya

Locations

Country	Name	City	State
Canada	Hôpital Sainte Justine	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Nicar Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective assessment of improvement of symptoms		4 weeks	No
Secondary	Change in severity of symptoms (likert scale)		4 weeks	No
Secondary	Presence and intensity of pain episodes		4 weeks	No
Secondary	Presence or absence of urgency, incomplete evacuation, gas		4 weeks	No
Secondary	Number and consistance of the stools		4 weeks	No
Secondary	School and social absenteism		4 weeks	No
Secondary	Quality of Life		4 weeks	No
Secondary	Adverse Events		2 months	Yes

External Links

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