Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified October 2013 by Bio-K Plus International Inc.
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT01545037
First received: March 1, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.


Condition Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: Lactobacillus acidophilus and Lactobacillus casei
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Lactobacillus Acidophilus CL1285 and Lactobacillus Casei LBC80R on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • IBS Adequate Relief (IBS-AR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The IBS-AR is a single-question dichotomous (yes/no) tool that asks subjects if they have experienced adequate relief of IBS symptoms over the past week.


Secondary Outcome Measures:
  • IBS Global Assessment of Improvement Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The IBS-GAI tool asks a single question regarding how recent IBS symptoms have changed since the start of the study. Subjects answer the question on a 1-7 Likert scale with 1 corresponding to "Substantially Worse" and 7 corresponding to "Substantially Improved".

  • IBS Symptom Severity Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale

  • IBS Quality of Life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The IBS-QOL is a 34-item questionnaire that assesses the degree to which IBS interfered with quality of life for a subject over the past 30 days. Each item is rated on a 1 to 5 Likert scale, with higher values indicating a lower quality of life.

  • Abdominal Pain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Abdominal pain severity will be measured on a 0-10 Likert scale.

  • Stool Consistency [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Stool consistency will be rated with the Bristol Stool Chart.

  • Stool frequency [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Throughout the study, subjects will record the number of defecations per day in a diary.

  • Concomitant medication use [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Throughout the study, subjects will record use of any concomitant medication and, if required, the need for rescue medication use each day in a diary.

  • Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Adverse events will be assessed throughout this clinical study. The main safety endpoint will be the proportion of subjects in each group that report one of more AEs at any time during the study.


Estimated Enrollment: 117
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic capsules
Lactobacillus acidophilus CL1285® + Lactobacillus casei LBC80R®
Dietary Supplement: Lactobacillus acidophilus and Lactobacillus casei
Each capsule contains of Lactobacillus acidophilus CL1285® + Lactobacillus casei LBC80R® contains50 billion cfu live bacteria. The randomized subjects will consume 2 capsules per day at breakfast.
Other Name: Bio-K+
Placebo Comparator: Placebo
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
Other: Placebo
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.

Detailed Description:

Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285® and Lactobacillus casei LBC80R®, on symptoms of IBS in otherwise healthy adults.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Subject meets Rome III criteria for IBS (regardless of IBS subtype) as follows:

    • Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with 2 or more of the following:

      • Improvement with defecation
      • Onset associated with a change in frequency of stool
      • Onset associated with a change in form (appearance) of stool
    • Symptom onset must be at least 6 months prior to diagnosis
  3. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
  4. Able to understand the nature and purpose of the study including potential risks and side effects
  5. Willing to consent to study participation and to comply with study requirements

    • Abdominal pain or discomfort at least 2 days during run-in period associated with 2 or more of the following:

      • Improvement with defecation
      • Onset associated with a change in frequency of stool
      • Onset associated with a change in form (appearance) of stool
    • Completion of all study-related questionnaires

Exclusion Criteria:

  1. Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer
  2. Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
  3. Any systemic disease that may confound IBS symptoms or compromise subject safety
  4. Life expectancy < 6 months
  5. Pregnant female or breastfeeding
  6. Lactose intolerance
  7. Immunodeficient subjects
  8. Uncontrolled psychiatric disorder
  9. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
  10. Eating disorder
  11. Recent (< 2 weeks) antibiotic administration
  12. History of alcohol, drug, or medication abuse
  13. Daily consumption of probiotics, fermented milk, and/or yogurt
  14. Known allergies to any substance in the study product
  15. Participation in another study with any investigational product within 3 months of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545037

Contacts
Contact: Karen Buchea Cravotto 1.415.291.2020 karen.cravotto@sprim.com

Locations
United States, California
Digestive and Liver Disease Specialists A Medical Group. Inc Recruiting
Garden Grove, California, United States, 92840
Principal Investigator: Syam P. Gaddam, MD         
Sprim ALS Recruiting
San Francisco, California, United States, 94109
Principal Investigator: Dalia Perleman, MS,RD,CDE         
Westlake Medical Research Recruiting
Westlake Village, California, United States, 91631
Principal Investigator: Razmig Krumian, DO         
Sponsors and Collaborators
Bio-K Plus International Inc.
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Dalia Perelman, MS,RD,CDE SPRIM ALS
Principal Investigator: Syam P. Gaddam, MD Digestive and Liver Disease Specialists A medical Group Inc.
Principal Investigator: Razming Krumian, DO Westlake Medical Research
  More Information

No publications provided

Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT01545037     History of Changes
Other Study ID Numbers: 111005-SCN-BIO-IBS-RA
Study First Received: March 1, 2012
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014