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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older 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 Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) Able to understand the nature and purpose of the study including potential risks and side effects 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: Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes Any systemic disease that may confound IBS symptoms or compromise subject safety Life expectancy < 6 months Pregnant female or breastfeeding Lactose intolerance Immunodeficient subjects Uncontrolled psychiatric disorder Current treatment with nasogastric tube, ostomy, or parenteral nutrition Eating disorder Recent (< 2 weeks) antibiotic administration History of alcohol, drug, or medication abuse Daily consumption of probiotics, fermented milk, and/or yogurt Known allergies to any substance in the study product Participation in another study with any investigational product within 3 months of screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic capsules<br>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®<br>* 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.<br>* Other names: Bio-K+;|
| Placebo Comparator: Placebo capsules<br>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<br>* The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.<br>|

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 |