VSL#3 Probiotic-mixture in Irritable Bowel Syndrome (IBS) Patients With Diarrhea
The objective of the proposed study is to assess the effect of VSL-#3 in terms of global relief, individual symptoms, health-related quality of life, and hs-CRP levels. The study hypothesis is that there will be a significant improvement in symptoms, stool consistency, and quality of life and a reduction in hs-CRP levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-controlled Crossover Study to Assess the Effect of the Probiotic VSL#3 on Symptom Relief and Indices of Micro-inflammation in IBS Patients With Diarrhea.|
- Symptom relief (abdominal pain and stool consistency) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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The definition of treatment responders is based on the FDA Draft Guidance for Clinical Evaluation of Products for Treatment of Irritable Bowel Syndrome.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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Blood will be drawn from patients and HC after a 12-hour fast and will be analyzed for hs-CRP.
- Improve the cholinergic status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Plasma cholinesterase catalytic activity measurements will involve adaptation of a spectrophotometric method to a microtiter plate assay
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: VSL#3
One standard package a day.
Dietary Supplement: VSL#3
Each package of VSL#3 probiotic medical food consists of 450 billion live freeze-dried lactic acid bacteria.
Each type of VSL#3 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 bulgaricus and Streptococcus thermophilus.
Other Name: Probiotic
Placebo Comparator: Placebo
Identical to the VSL#3 powder: same taste, same colour, same appearance
Probiotic treatment in IBS is safe and effective. Probiotics have been shown to improve the anti-inflammatory/proinflammatory ratio, and may also improve intestinal motility, and the bacterial composition of the intestines. The probiotic VSL-#3 improves IBS symptoms, especially bloating, in children and adults. Patients with post-infectious IBS, as well as many patients with "classic" IBS, manifest a low-grade inflammatory state that may be associated with visceral hypersensitivity and impaired motility. Probiotics may suppress this low-grade inflammation. In a recent study we found that highly sensitive CRP (hs-CRP), a serum marker of micro-inflammation, was significantly higher in patients with diarrhea-predominant IBS than healthy controls, although within normal limits in both groups. Thus, hs-CRP may serve as a marker of this low-grade, sub-clinical inflammation. If treatment with VSL-#3 reduces the degree of low-grade inflammation in IBS, the improvement may be reflected in reduced hs-CRP levels. This study can contribute to our understanding of the pathophysiology of IBS and provide further evidence for the effectiveness of VSL-#3 in its treatment.
|Contact: Keren Hod, MsCfirstname.lastname@example.org|
|Tel-Aviv Sourasky Medical Center||Not yet recruiting|
|Tel-Aviv, Central Israel, Israel|
|Principal Investigator: Roy Dekel, MD|
|Study Director:||Ami Sperber, MD||Tel Aviv Medical Center|
|Principal Investigator:||Roy Dekel, MD||Tel Aviv Medical Center|