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

Primary Purpose

Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Kyodophilus multi-strain probiotic capsules
Kyodophilus Matching Placebo Capsules
Sponsored by
The Canadian College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring bloating, constipation, diarrhea, gas, mucous, cramping

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Canadian College of Naturopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Kyodophilus matching placebo capsules

Kyodophilus multi strain probiotic capsules

Arm Description

Outcomes

Primary Outcome Measures

The irrtable bowel severity scoring system is the primary outcome measure
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.
The Irritable Bowel Syndrome-Quality of Life Questionnaire
This is a validated quality of life questionnaire (Patrick et al, 1998)
Visual Analogue Scale
Patient rated 0-6 (7 point)questionnaire on the severity of IBS symptoms

Full Information

First Posted
May 31, 2010
Last Updated
March 31, 2011
Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Wakunaga Pharmaceutical Co., Ltd., Dicentra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01176227
Brief Title
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
Official Title
The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Irritable Bowel Syndrome (IBS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Wakunaga Pharmaceutical Co., Ltd., Dicentra Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 IBS.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional, Colitis, Mucous, Colon, Irritable
Keywords
bloating, constipation, diarrhea, gas, mucous, cramping

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kyodophilus matching placebo capsules
Arm Type
Placebo Comparator
Arm Title
Kyodophilus multi strain probiotic capsules
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Kyodophilus multi-strain probiotic capsules
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Kyodophilus Matching Placebo Capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
The irrtable bowel severity scoring system is the primary outcome measure
Description
Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).
Time Frame
12 weeks (between baseline and end of study)
Secondary Outcome Measure Information:
Title
Tolerability of the treatment will be assessed through the use of study diaries in which adverse events will be recorded.
Time Frame
12 weeks
Title
The Irritable Bowel Syndrome-Quality of Life Questionnaire
Description
This is a validated quality of life questionnaire (Patrick et al, 1998)
Time Frame
12 weeks (baseline and end of study)
Title
Visual Analogue Scale
Description
Patient rated 0-6 (7 point)questionnaire on the severity of IBS symptoms
Time Frame
12 weeks (baseline and end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dugald Seely, ND
Organizational Affiliation
The Canadian College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Canadian College of Naturopathic Medicine
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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