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

NCT01887834 | Completed Phase 1 DMC

• 1 other identifier: 1302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 severe IBS.

Conditions

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

Keywords

bloating; constipation; diarrhea; gas; mucous; cramping

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome Severity

  Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).

  12 weeks

Secondary Outcomes (1)

• Tolerability of the treatment

  12 weeks

Other Outcomes (2)

• The Irritable Bowel Syndrome-Quality of Life Questionnaire

  12 weeks

• Adequate Response Criteria

  12 weeks

Study Arms (2)

Kyodophilus matching placebo capsules

PLACEBO COMPARATOR

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.

Dietary Supplement: Kyodophilus Matching Placebo Capsules

Kyodophilus multi strain probiotic capsules

ACTIVE COMPARATOR

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 multi-strain probiotic capsules

Interventions

Kyodophilus multi-strain probiotic capsules DIETARY_SUPPLEMENT

Kyodophilus multi strain probiotic capsules

Kyodophilus Matching Placebo Capsules DIETARY_SUPPLEMENT

Kyodophilus matching placebo capsules

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged 18-64.
• A diagnosis of Irritable Bowel Syndrome as per ROME III criteria.
• A classification of severe irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score \>300).
• 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.

You may not qualify if:

• 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 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 (\>3 times weekly) consuming probiotics enriched products (e.g. probiotic enriched yogurts, Activia, etc…).
• Subjects who have recently (\< 3 months) initiated dietary measures to control IBS symptoms, such as elimination of certain foods.
• 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 that require medication for treatment of IBS symptoms.
• Subjects with weight loss, anemia, inflammatory bowel disease, or celiac sprue, and 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 thyroid function tests, blood counts and serum chemistry.

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Wakunaga Pharmaceutical Co., Ltd.: collaborator
• Dicentra Inc.: collaborator

Study Sites (1)

The Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Digestive System Diseases; Colonic Diseases, Functional; Constipation; Diarrhea; Mucopolysaccharidosis IV; Spasm

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Dugald Seely, ND

  The Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

CA (1)