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

Irritable Bowel Syndrome Clinical Trial

Official title:

Exploring the Mechanism of a Probiotic Combination VSL#3 in Irritable Bowel Syndrome: a Randomized Double Blind Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786123
• Other study ID #: D/06/136
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: March 2, 2011
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• VSL#3
Dose: 4 capsules of VSL#3 daily for 6 weeks.
• Placebo
Identical looking preparation of placebo taken at the same dose regimen as the active comparator

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Camilleri M. Is there a role for probiotics in irritable bowel syndrome? Dig Liver Dis. 2006 Dec;38 Suppl 2:S266-9. Review. — View Citation

Shen B, Brzezinski A, Fazio VW, Remzi FH, Achkar JP, Bennett AE, Sherman K, Lashner BA. Maintenance therapy with a probiotic in antibiotic-dependent pouchitis: experience in clinical practice. Aliment Pharmacol Ther. 2005 Oct 15;22(8):721-8. — View Citation

Song GH, Leng PH, Gwee KA, Moochhala SM, Ho KY. Melatonin improves abdominal pain in irritable bowel syndrome patients who have sleep disturbances: a randomised, double blind, placebo controlled study. Gut. 2005 Oct;54(10):1402-7. Epub 2005 May 24. — View Citation

Song GH, Venkatraman V, Ho KY, Chee MW, Yeoh KG, Wilder-Smith CH. Cortical effects of anticipation and endogenous modulation of visceral pain assessed by functional brain MRI in irritable bowel syndrome patients and healthy controls. Pain. 2006 Dec 15;126(1-3):79-90. Epub 2006 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of symptoms		6 weeks
Secondary	Rectal sensitivity		6 weeks
Secondary	Saliva and fecal melatonin levels		6 weeks