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

Overview

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.

Full Title of Study: “Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2015

Interventions

  • 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™)
  • Other: Placebo
    • Placebo composition matodextrin, gelatin, ascorbic acid, soya

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Subjective assessment of improvement of symptoms
    • Time Frame: 4 weeks

Secondary Measures

  • Change in severity of symptoms (likert scale)
    • Time Frame: 4 weeks
  • Presence and intensity of pain episodes
    • Time Frame: 4 weeks
  • Presence or absence of urgency, incomplete evacuation, gas
    • Time Frame: 4 weeks
  • Number and consistance of the stools
    • Time Frame: 4 weeks
  • School and social absenteism
    • Time Frame: 4 weeks
  • Quality of Life
    • Time Frame: 4 weeks
  • Adverse Events
    • Time Frame: 2 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Justine’s Hospital
  • Collaborator
    • Nicar Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christophe Faure, MD – St. Justine’s Hospital
  • Overall Official(s)
    • Christophe M Faure, MD, Principal Investigator, Ste-Justine Hospital

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