Exploring the Mechanism of a Probiotic Combination VSL#3 in Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00786123
First received: November 4, 2008
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Existing therapies for IBS are still far from satisfactory and new therapies are being constantly sought. Probiotics are promising candidate for the prevention and treatment of IBS. However, its efficacy and mechanism is still unclear. The current study aims to evaluate the effects of a combination probiotic, VSL#3, on symptoms and rectal sensitivity in patients with IBS. The underlying mechanism will also be investigated. We will recruit forty patients with Rome III IBS and randomized them, in a parallel group, double-blinded design, to take four VSL#3 capsules or placebos, twice daily, for six weeks. Before and after treatment, patients will be assessed for their symptoms, rectal sensitivity, as well as saliva and fecal melatonin levels. Bowel symptom diary and weekly satisfactory relief of bowel symptoms will also be recorded and evaluated.


Condition Intervention
Irritable Bowel Syndrome
Dietary Supplement: VSL#3
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Exploring the Mechanism of a Probiotic Combination VSL#3 in Irritable Bowel Syndrome: a Randomized Double Blind Placebo Controlled Study

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Resolution of symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rectal sensitivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Saliva and fecal melatonin levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VSL#3
Patients taking probiotics (VSL#3)
Dietary Supplement: VSL#3
Dose: 4 capsules of VSL#3 daily for 6 weeks.
Other Name: probiotics
Placebo Comparator: Placebo
Identical looking preparation of placebo taken at the same dose regimen as the active comparator
Dietary Supplement: Placebo
Identical looking preparation of placebo taken at the same dose regimen as the active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male patients with IBS between the ages of 18 and 68 will be recruited. IBS will be diagnosed according to the Rome III diagnostic criteria (Drossman and Dumitrascu, 2006). The history of previous chronic GI symptoms suggestive of IBS should be at least 3 months (not necessarily consecutive) over the preceding 6 months. The stool culture of each subject should be negative for hemoccult, pathogens (Salmonella and Shigella), parasites (Giardia) and ova/ cyst. Only patients who had IBS symptoms for at least one month prior to the study and whose IBS symptom score is of at least a moderate severity on at least one of IBS symptoms will be eligible for inclusion into the study.

Exclusion Criteria:

  • Those subjects who are unwilling or unable to give informed consent, follow protocol or to stop all medications used to treat diarrhoea or colitis
  • Subject taking at the time of proposed enrolment any of the below listed prohibited medications:

    • Anticholinergics (dicyclomine, hyoscyamine, propantheline)
    • Cholinomimetic agents (bethanechol etc.)
    • All narcotics (morphine, codeine, propoxyphene either alone or in any
    • combination)
    • 5-HT3 receptor antagonists (e.g., alosetron, ondansetron, tropisetron, dolasetron, granisetron).
    • Gastrointestinal preparations:
    • Antacids (containing either magnesium or aluminium)
    • Antidiarrheal agents
    • Bismuth compounds
    • Laxatives (stimulant or osmotic)
    • Sulfasalazine
  • Treatment with immunosuppressive medications or presence of an immunocompromised state
  • If currently using medication (like those used in Diabetes mellitus, Sarcoidosis, Connective tissue disease, poorly controlled hypo/hyperthyroidism) may alter bowel motility or if under long term antibiotic therapy
  • Use of any other investigational drug and/or participation in any clinical trial within 3 months of entry to this study
  • Patients will be excluded if they had undergone previous abdominal surgery (except appendectomy, Caesarean section, Cholecystectomy, Tubal ligation, Hysterectomy, Hernia repair ≥ 6 months prior to enrolment)
  • Subject who has been diagnosed with any of the following GI disorders:

    • Inflammatory bowel disease (Crohn's disease, Ulcerative colitis, Indeterminate Colitis
    • Microscopic colitis (lymphocytic colitis, collagenous colitis)
    • Celiac Disease
    • Gastroparesis
    • Gastrointestinal obstruction and/or stricture
    • Chronic pancreatitis
  • Subject with a significant concomitant psychiatric, neurological, metabolic, renal, hepatic, infections, hematological, C.V or pulmonary illness, unless condition is stable and judged by the investigator that such condition does not interfere with the patients participation in the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00786123

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Ho Khek Yu National University Hospital, Singapore
  More Information

Publications:
Responsible Party: Khek Yu Ho / Professor, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00786123     History of Changes
Other Study ID Numbers: D/06/136
Study First Received: November 4, 2008
Last Updated: March 2, 2011
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
irritable bowel syndrome
rectal hypersensitivity
probiotics
melatonin
brain-gut axis

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014