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

Bio-K Plus

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01545037

111005-SCN-BIO-IBS-RA

Details and patient eligibility

About

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

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 2 patient groups, including a placebo group

Probiotic capsules

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®

Placebo capsules

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo