- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667627
Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea (IBS-D)
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Central Israel
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Tel-Aviv, Central Israel, Israel
- Tel-Aviv Sourasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A diagnosis of IBS-D according to the Rome III criteria, agreement to participate and the ability to sign an informed consent. Moreover, the definition of inclusion criteria is based on the FDA Draft Guidance for Clinical Evaluation of Products (add ref here). Over the two week run-in period:
- Pain Intensity: weekly average of worst abdominal pain in past 24 hours score of ≥ 3.0 on a 0 (no pain at all) to 10 (worst possible pain) point scale
- Stool Consistency: ≥30% of days/week with at least one stool ≥6 using the Bristol Stool Score (BSS, Fig. 1) (ref).
Exclusion Criteria:
1) Hyperthyroidism, 2) celiac disease 3) pregnancy, 4) other gastrointestinal diagnoses that might interfere with the study (e.g. active peptic disease, inflammatory bowel disease), 5) a history of malignancy that might, to the best judgment of the doctor, interfere with the study, 6) any infectious or inflammatory disease within the last month, 7) active medically treated asthma, 8) baseline levels of HsCRP > 10mg/liter, 9) steroid treatment for any indication, 10) fecal incontinence, and 11) treatment with probiotics or antibiotics of any kind within the last 4 weeks, 11) Diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BIO-25, Probiotic-mixture
Two capsules a day.
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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 Names:
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Placebo Comparator: Placebo
Identical to the Bio-25 capsule: same taste, same colour, same appearance
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Identical placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom relief (abdominal pain and stool consistency)
Time Frame: 8 weeks
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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.
|
8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in other specific IBS symptoms, i.e., gas and bloating, feeling of urgency
Time Frame: 8 weeks
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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).
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8 weeks
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Reduce hs-CRP levels
Time Frame: 8 weeks
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Blood will be drawn from IBS-D patients after a 12-hour fast and will be analyzed for hs-CRP.
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8 weeks
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Improve the cholinergic status
Time Frame: 8 weeks
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Plasma cholinesterase catalytic activity measurements will involve adaptation of a spectrophotometric method to a microtiter plate assay
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8 weeks
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Reduce calprotectin levels
Time Frame: 8 weeks
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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). |
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ami Sperber, MD, Tel Aviv Medical Center
- Principal Investigator: Roy Dekel, MD, Tel Aviv Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-11-RD-0491-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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