Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
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
1 other identifier
interventional
117
1 country
3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJuly 31, 2017
April 1, 2015
2.5 years
March 1, 2012
July 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
IBS Global Assessment of Improvement Scale
12 weeks
IBS Symptom Severity Scale
12 Weeks
IBS Quality of Life
12 Weeks
Abdominal Pain
12 Weeks
Stool Consistency
12 Weeks
- +3 more secondary outcomes
Study Arms (2)
Probiotic capsules
ACTIVE COMPARATORL. 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.
Placebo capsules
PLACEBO COMPARATORThe 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
Interventions
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.
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bio-K Plus International Inc.lead
- Sprim Advanced Life Sciencescollaborator
Study Sites (3)
Digestive and Liver Disease Specialists A Medical Group. Inc
Garden Grove, California, 92840, United States
Sprim ALS
San Francisco, California, 94109, United States
Westlake Medical Research
Westlake Village, California, 91631, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dalia Perelman, MS,RD,CDE
SPRIM ALS
- PRINCIPAL INVESTIGATOR
Syam P. Gaddam, MD
Digestive and Liver Disease Specialists A medical Group Inc.
- PRINCIPAL INVESTIGATOR
Razming Krumian, DO
Westlake Medical Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2012
First Posted
March 6, 2012
Study Start
July 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
July 31, 2017
Record last verified: 2015-04