Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea (IBS-D)
|ClinicalTrials.gov Identifier: NCT01667627|
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|IBS||Dietary Supplement: Bio-25 Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled Study to Assess the Effect of Probiotic on Symptom Relief and Indices of Micro-inflammation and Cholinergic Status in IBS Patients With Diarrhea.|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: BIO-25, Probiotic-mixture
Two capsules a day.
Dietary Supplement: Bio-25
Each capsule of the multispecies probiotic combination Bio-25 consists of 25 billion live bacteria.
Each type of bio-25 contains billions of live lactic acid bacteria in defined ratios of lyophilized Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasein, Lactobacillus casei, Bifidobacterium bifidum,Lactobacillus lactis, Lactobacillus rhamnosus,and Streptococcus thermophilus.
Other Name: Probiotic
Placebo Comparator: Placebo
Identical to the Bio-25 capsule: same taste, same colour, same appearance
- Symptom relief (abdominal pain and stool consistency) [ Time Frame: 8 weeks ]
Abdominal pain intensity, stool consistency, will be assessed by visual analogue scales (VAS) with scales from 0 (no symptom at all) to 10 (the worst possible symptom.
The definition of treatment responders is based on the FDA Draft Guidance for Clinical Evaluation of Products for Treatment of Irritable Bowel Syndrome.
- A Pain Intensity Responder is a patient who experiences a 30% or greater decrease in the weekly average of worst abdominal pain in past 24 hours in the past 24 hours compared to baseline.
- A Stool Consistency Responder is a patient who has a greater than 50% decrease in the number of days with at least one stool ≥ type 6 using the Bristol Stool Scale (BSS).
- A patient will be classified as an overall responder if they achieve the above improvement in pain intensity and stool consistency for at least 50 percent of the time.
- Improvement in other specific IBS symptoms, i.e., gas and bloating, feeling of urgency [ Time Frame: 8 weeks ]Specific IBS symptoms, i.e., gas and bloating, feeling of urgency, will be assessed by visual analogue scales (VAS) with scales from 0 (no symptom at all) to 10 (the worst possible symptom).
- Reduce hs-CRP levels [ Time Frame: 8 weeks ]Blood will be drawn from IBS-D patients after a 12-hour fast and will be analyzed for hs-CRP.
- Improve the cholinergic status [ Time Frame: 8 weeks ]Plasma cholinesterase catalytic activity measurements will involve adaptation of a spectrophotometric method to a microtiter plate assay
- Reduce calprotectin levels [ Time Frame: 8 weeks ]
At the beginning and at the end of the treatment period, fecal samples will be obtained for the measurement of calprotectin levels.
The quantitative concentration of calprotectin will be determined by enzyme linked immunosorbent assay (ELISA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667627
|Tel-Aviv Sourasky Medical Center|
|Tel-Aviv, Central Israel, Israel|
|Study Director:||Ami Sperber, MD||Tel Aviv Medical Center|
|Principal Investigator:||Roy Dekel, MD||Tel Aviv Medical Center|