Back to resultsEffect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
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
Sites / Locations
- Digestive and Liver Disease Specialists A Medical Group. Inc
- Sprim ALS
- Westlake Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic capsules
Placebo capsules
Arm 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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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".
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
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.
Abdominal Pain
Abdominal pain severity will be measured on a 0-10 Likert scale.
Stool Consistency
Stool consistency will be rated with the Bristol Stool Chart.
Stool frequency
Throughout the study, subjects will record the number of defecations per day in a diary.
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.
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.
Full Information
NCT ID
NCT01545037
First Posted
March 1, 2012
Last Updated
July 27, 2017
Sponsor
Bio-K Plus International Inc.
Collaborators
Sprim Advanced Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01545037
Brief Title
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio-K Plus International Inc.
Collaborators
Sprim Advanced Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic capsules
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®
Other Intervention Name(s)
Bio-K+
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
Primary Outcome Measure Information:
Title
IBS Adequate Relief (IBS-AR)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
IBS Global Assessment of Improvement Scale
Description
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".
Time Frame
12 weeks
Title
IBS Symptom Severity Scale
Description
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
Time Frame
12 Weeks
Title
IBS Quality of Life
Description
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.
Time Frame
12 Weeks
Title
Abdominal Pain
Description
Abdominal pain severity will be measured on a 0-10 Likert scale.
Time Frame
12 Weeks
Title
Stool Consistency
Description
Stool consistency will be rated with the Bristol Stool Chart.
Time Frame
12 Weeks
Title
Stool frequency
Description
Throughout the study, subjects will record the number of defecations per day in a diary.
Time Frame
12 Weeks
Title
Concomitant medication use
Description
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.
Time Frame
12 Weeks
Title
Adverse Events
Description
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.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia Perelman, MS,RD,CDE
Organizational Affiliation
SPRIM ALS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syam P. Gaddam, MD
Organizational Affiliation
Digestive and Liver Disease Specialists A medical Group Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Razming Krumian, DO
Organizational Affiliation
Westlake Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive and Liver Disease Specialists A Medical Group. Inc
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Sprim ALS
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91631
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
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