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

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ClinicalTrials.gov Identifier: NCT01176227
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : April 1, 2011
Sponsor:
Collaborators:
Wakunaga Pharmaceutical Co., Ltd.
Dicentra Inc.
Information provided by:
The Canadian College of Naturopathic Medicine

May 31, 2010
August 5, 2010
April 1, 2011
May 2010
February 2011   (Final data collection date for primary outcome measure)
The irrtable bowel severity scoring system is the primary outcome measure [ Time Frame: 12 weeks (between baseline and end of study) ]
Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).
Same as current
Complete list of historical versions of study NCT01176227 on ClinicalTrials.gov Archive Site
  • Tolerability of the treatment will be assessed through the use of study diaries in which adverse events will be recorded. [ Time Frame: 12 weeks ]
  • The Irritable Bowel Syndrome-Quality of Life Questionnaire [ Time Frame: 12 weeks (baseline and end of study) ]
    This is a validated quality of life questionnaire (Patrick et al, 1998)
  • Visual Analogue Scale [ Time Frame: 12 weeks (baseline and end of study) ]
    Patient rated 0-6 (7 point)questionnaire on the severity of IBS symptoms
Same as current
Not Provided
Not Provided
 
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Irritable Bowel Syndrome (IBS)

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Digestive System Diseases
  • Colonic Diseases, Functional
  • Colitis, Mucous
  • Colon, Irritable
  • 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.

  • 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.
  • Placebo Comparator: Kyodophilus matching placebo capsules
    Intervention: Dietary Supplement: Kyodophilus Matching Placebo Capsules
  • Active Comparator: Kyodophilus multi strain probiotic capsules
    Intervention: Dietary Supplement: Kyodophilus multi-strain probiotic capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
Same as current
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01176227
1001
Yes
Not Provided
Not Provided
Dugald Seely, The Canadian College of Naturopathic Medicine
The Canadian College of Naturopathic Medicine
  • Wakunaga Pharmaceutical Co., Ltd.
  • Dicentra Inc.
Principal Investigator: Dugald Seely, ND The Canadian College of Naturopathic Medicine
The Canadian College of Naturopathic Medicine
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP