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| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
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The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic capsules | Active Comparator | 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. |
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| Placebo capsules | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 12 weeks |
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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:
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:
Completion of all study-related questionnaires
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive and Liver Disease Specialists A Medical Group. Inc | Garden Grove | California | 92840 | United States | ||
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Other | The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria. |
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| 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 |
| 12 Weeks |
| 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. | 12 Weeks |
| Abdominal Pain | Abdominal pain severity will be measured on a 0-10 Likert scale. | 12 Weeks |
| Stool Consistency | Stool consistency will be rated with the Bristol Stool Chart. | 12 Weeks |
| Stool frequency | Throughout the study, subjects will record the number of defecations per day in a diary. | 12 Weeks |
| 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. | 12 Weeks |
| 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. | 12 Weeks |
| Sprim ALS |
| San Francisco |
| California |
| 94109 |
| United States |
| Westlake Medical Research | Westlake Village | California | 91631 | United States |
| D004066 | Digestive System Diseases |