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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786123
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : March 4, 2011
Information provided by:
National University Hospital, Singapore

Brief Summary:
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 or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: VSL#3 Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Resolution of symptoms [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Rectal sensitivity [ Time Frame: 6 weeks ]
  2. Saliva and fecal melatonin levels [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786123

National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Ho Khek Yu National University Hospital, Singapore

Responsible Party: Khek Yu Ho / Professor, National University Hospital, Singapore Identifier: NCT00786123     History of Changes
Other Study ID Numbers: D/06/136
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: March 2011

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

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