Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome

NCT01887834 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-03-17

No results posted yet for this study

Summary

The Canadian College of Naturopathic Medicine is conducting a research study on Irritable Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and bloating.

The medicines that are currently used to help people with IBS are not as effective as we would like them to be. These medicines are usually only prescribed to reduce the pain of IBS and not actually treat the disorder itself. Recently, scientists have found that probiotics (beneficial bacteria that live inside humans) may help reduce the painful symptoms and diarrhea that are part of IBS.

This research is being conducted to determine whether this particular combination of three probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum) will reduce the symptoms of severe IBS.

Conditions

  • Irritable Bowel Syndrome
  • Digestive System Diseases
  • Colonic Diseases, Functional
  • Colitis, Mucous
  • Colon, Irritable

Interventions

DIETARY_SUPPLEMENT

Kyodophilus multi-strain probiotic capsules

DIETARY_SUPPLEMENT

Kyodophilus Matching Placebo Capsules

Sponsors & Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

    collaborator INDUSTRY
  • Dicentra Inc.

    collaborator INDUSTRY
  • The Canadian College of Naturopathic Medicine

    lead OTHER

Principal Investigators

  • Dugald Seely, ND · The Canadian College of Naturopathic Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887834 on ClinicalTrials.gov