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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Placebo; Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®

• Registration Number: NCT01545037
• Lead Sponsor: Bio-K Plus International Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Study Start: 2012-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo capsules	Placebo	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
Probiotic capsules	L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®	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.

Primary Outcome Measures

Name	Time	Method
IBS Adequate Relief (IBS-AR)	12 weeks	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

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

Trial Locations

Locations (3)

Digestive and Liver Disease Specialists A Medical Group. Inc; 🇺🇸 Garden Grove, California, United States

Sprim ALS; 🇺🇸 San Francisco, California, United States

Westlake Medical Research; 🇺🇸 Westlake Village, California, United States