Irritable Bowel Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTL. 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.
OTHERPlacebo
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
Sponsors
Sprim Advanced Life Sciences
Bio-K Plus International Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Stool frequency | 12 Weeks | Throughout the study, subjects will record the number of defecations per day in a diary. |
| 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. |
| 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. |
| Stool Consistency | 12 Weeks | Stool consistency will be rated with the Bristol Stool Chart. |
Countries
United States
Outcome results
None listed