Clinical trial NCT01545037: Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Bio-K Plus International Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2012-03-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: IBS Adequate Relief (IBS-AR)
timeFrame: 12 weeks
Secondary outcomes:
measure: IBS Global Assessment of Improvement Scale
timeFrame: 12 weeks
measure: IBS Symptom Severity Scale
timeFrame: 12 Weeks
measure: IBS Quality of Life
timeFrame: 12 Weeks
measure: Abdominal Pain
timeFrame: 12 Weeks
measure: Stool Consistency
timeFrame: 12 Weeks
measure: Stool frequency
timeFrame: 12 Weeks
measure: Concomitant medication use
timeFrame: 12 Weeks
measure: Adverse Events
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Digestive and Liver Disease Specialists A Medical Group. Inc
state: California
city: San Francisco
country: United States
facility: Sprim ALS
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
Study officials:
affiliation: SPRIM ALS
name: Dalia Perelman, MS,RD,CDE
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive and Liver Disease Specialists A medical Group Inc.
name: Syam P. Gaddam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westlake Medical Research
name: Razming Krumian, DO
role: PRINCIPAL_INVESTIGATOR
References: