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

This study has been completed.
Sponsor:
Collaborators:
Wakunaga Pharmaceutical Co., Ltd.
Dicentra Inc.
Information provided by:
The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT01176227
First received: May 31, 2010
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

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 IBS.


Condition Intervention Phase
Irritable Bowel Syndrome
Digestive System Diseases
Colonic Diseases, Functional
Colitis, Mucous
Colon, Irritable
 Dietary Supplement: Kyodophilus multi-strain probiotic capsules
Dietary Supplement: Kyodophilus Matching Placebo Capsules
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Irritable Bowel Syndrome (IBS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • The irrtable bowel severity scoring system is the primary outcome measure [ Time Frame: 12 weeks (between baseline and end of study) ] [ Designated as safety issue: No ]
    Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).


Secondary Outcome Measures:
  • Tolerability of the treatment will be assessed through the use of study diaries in which adverse events will be recorded. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The Irritable Bowel Syndrome-Quality of Life Questionnaire [ Time Frame: 12 weeks (baseline and end of study) ] [ Designated as safety issue: No ]
    This is a validated quality of life questionnaire (Patrick et al, 1998)

  • Visual Analogue Scale [ Time Frame: 12 weeks (baseline and end of study) ] [ Designated as safety issue: No ]
    Patient rated 0-6 (7 point)questionnaire on the severity of IBS symptoms


Estimated Enrollment: 128
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Kyodophilus matching placebo capsules Dietary Supplement: Kyodophilus Matching Placebo Capsules
Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.
Active Comparator: Kyodophilus multi strain probiotic capsules Dietary Supplement: Kyodophilus multi-strain probiotic capsules

The Kyo-Dophilus study product is a gelatin capsule containing three proprietary probiotic bacterial strains. The total quantity of bacteria per capsule is 1.5 billion colony forming units (1.5 x 109 cfu) and is composed of the following strains:

  • Lactobacillus gasseri KS-13 1.2
  • Bifidobacterium bifidum G9-1 0.15
  • Bifidobacterium longum MM-2 0.15

Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.

Detailed Description:

The purpose of this trial is to investigate the effects of the three strain probiotic, Kyo-Dophilus, on the symptoms associated with Irritable Bowel Syndrome.

The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with Irritable Bowel Syndrome by ROME III criteria and classified as mild through the Irritable Bowel Severity Scoring System and to measuring quality of life and global well being of patients through the Visual Analog Scale and the Irritable Bowel Syndrome-Quality of Life Questioner. The secondary objective is to assess the tolerability of the treatment through the use of study diaries.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 18-64
  • A diagnosis of Irritable Bowel Syndrome as per ROME III criteria
  • A classification of mild irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score >75)
  • Female subjects currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods)
  • Subjects who agree to maintain their current eating habits throughout the study
  • Ability to understand and sign the Informed Consent Form

Exclusion Criteria:

  • Female subjects who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months
  • Subjects currently receiving medication for the treatment of IBS symptoms
  • Subjects currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the trial is they agree to undergo a two week washout period
  • Subjects currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
  • Subjects who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
  • Subjects currently receiving antibiotic therapy or antibiotic therapy within the previous month
  • Subjects regularly consuming probiotic containing products (e.g. yogurts, etc.)
  • Subjects who have recently (< 3 months) initiated dietary measures to control IBS symptoms
  • Subjects with a history of major or complicated gastrointestinal surgery
  • Subjects with severe endometriosis
  • Subjects with malignant tumors or subjects undergoing chemotherapy or radiation therapy
  • Subjects with severe IBS and that require medication
  • Subjects with weight loss, anaemia, inflammatory bowel disease, celiac sprue, family history of colorectal cancer
  • Subjects exhibiting or indicating thoughts of suicide currently or in the past as based on patient screening interview by the investigator/clinician. Appropriate referral to a health care provider will be provided
  • Subjects with known allergies to milk or milk based products
  • Subjects using and/or have used antipsychotic or anticholinergic medication within the prior month, those with reported significant abnormalities on the thyroid function tests, blood counts and serum chemistry
  • Subjects 50 years or older who have been diagnosed with IBS and have not received a colonoscopy in the last five years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176227

Locations
Canada, Ontario
The Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Wakunaga Pharmaceutical Co., Ltd.
Dicentra Inc.
Investigators
Principal Investigator: Dugald Seely, ND The Canadian College of Naturopathic Medicine
  More Information

No publications provided

Responsible Party: Dugald Seely, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT01176227     History of Changes
Other Study ID Numbers: 1001
Study First Received: May 31, 2010
Last Updated: March 31, 2011
Health Authority: Canada: Health Canada

Keywords provided by The Canadian College of Naturopathic Medicine:
bloating
constipation
diarrhea
 gas
mucous
cramping

Additional relevant MeSH terms:
Colitis
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
 Gastrointestinal Diseases
Irritable Bowel Syndrome
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on May 21, 2013