Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
|ClinicalTrials.gov Identifier: NCT01545037|
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Active Comparator: Probiotic capsules
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.
Dietary Supplement: L. 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.
Other Name: Bio-K+
Placebo Comparator: Placebo capsules
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
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
- IBS Adequate Relief (IBS-AR) [ Time Frame: 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.
- IBS Global Assessment of Improvement Scale [ Time Frame: 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".
- IBS Symptom Severity Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 Weeks ]Abdominal pain severity will be measured on a 0-10 Likert scale.
- Stool Consistency [ Time Frame: 12 Weeks ]Stool consistency will be rated with the Bristol Stool Chart.
- Stool frequency [ Time Frame: 12 Weeks ]Throughout the study, subjects will record the number of defecations per day in a diary.
- Concomitant medication use [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545037
|United States, California|
|Digestive and Liver Disease Specialists A Medical Group. Inc|
|Garden Grove, California, United States, 92840|
|San Francisco, California, United States, 94109|
|Westlake Medical Research|
|Westlake Village, California, United States, 91631|
|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|