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

Effect of Lactobacillus Acidophilus CL1285®, L. Casei LBC80R® and L. Rhamnosus CLR2® on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®; Other: Placebo

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®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92840
      • Digestive and Liver Disease Specialists A Medical Group. Inc
    • San Francisco, California, United States, 94109
      • Sprim ALS
    • Westlake Village, California, United States, 91631
      • Westlake Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic capsules; L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks.	Dietary supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®; Each capsule contains 50 billion cfu live of Lactobacillus acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® bacterias. The randomized subjects will consume 2 capsules per day at breakfast.; Other Names: Bio-K+
Placebo Comparator: Placebo capsules; The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks	Other: Placebo; The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS Adequate Relief (IBS-AR)	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS Global Assessment of Improvement Scale	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".	12 weeks
IBS Symptom Severity Scale	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	12 Weeks
IBS Quality of Life	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.	12 Weeks
Abdominal Pain	Abdominal pain severity will be measured on a 0-10 Likert scale.	12 Weeks
Stool Consistency	Stool consistency will be rated with the Bristol Stool Chart.	12 Weeks
Stool frequency	Throughout the study, subjects will record the number of defecations per day in a diary.	12 Weeks
Concomitant medication use	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.	12 Weeks
Adverse Events	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.	12 Weeks

Collaborators and Investigators

• Sponsor: Bio-K Plus International Inc.
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 6, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 111005-SCN-BIO-IBS-RA