VSL#3 Probiotic-mixture in Irritable Bowel Syndrome (IBS) Patients With Diarrhea
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
IBS |
Dietary Supplement: VSL#3 |
Phase 4 |
| Study Type: | Interventional |
| 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The definition of treatment responders is based on the FDA Draft Guidance for Clinical Evaluation of Products for Treatment of Irritable Bowel Syndrome.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
| Estimated Enrollment: | 120 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Keren Hod, MsC | 97236974280 | hodkeren@gmail.com |
| Israel | |
| 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 |
More Information
No publications provided
| Responsible Party: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01667627 History of Changes |
| Other Study ID Numbers: | TASMC-11-RD-0491-CTIL |
| Study First Received: | August 15, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
IBS Probiotic hs-CRP Cholinergic status VSL#3 |
Additional relevant MeSH terms:
|
Diarrhea Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013