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

NCT00786123 | Completed

• 1 other identifier: D/06/136
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; rectal hypersensitivity; probiotics; melatonin; brain-gut axis

Outcome Measures

Primary Outcomes (1)

• Resolution of symptoms

  6 weeks

Secondary Outcomes (2)

• Rectal sensitivity

  6 weeks

• Saliva and fecal melatonin levels

  6 weeks

Study Arms (2)

VSL#3

EXPERIMENTAL

Patients taking probiotics (VSL#3)

Dietary Supplement: VSL#3

Placebo

PLACEBO COMPARATOR

Identical looking preparation of placebo taken at the same dose regimen as the active comparator

Dietary Supplement: Placebo

Interventions

VSL#3 DIETARY_SUPPLEMENT

Dose: 4 capsules of VSL#3 daily for 6 weeks.

Also known as: probiotics

VSL#3

Placebo DIETARY_SUPPLEMENT

Identical looking preparation of placebo taken at the same dose regimen as the active comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (4)

• Camilleri M. Is there a role for probiotics in irritable bowel syndrome? Dig Liver Dis. 2006 Dec;38 Suppl 2:S266-9. doi: 10.1016/S1590-8658(07)60007-3.

  PMID: 17259088 BACKGROUND

• 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. doi: 10.1111/j.1365-2036.2005.02642.x.

  PMID: 16197493 BACKGROUND

• 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. doi: 10.1016/j.pain.2006.06.017. Epub 2006 Jul 18.

  PMID: 16846694 BACKGROUND

• 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. doi: 10.1136/gut.2004.062034. Epub 2005 May 24.

  PMID: 15914575 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ho Khek Yu

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 6, 2008
• Study Start: May 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 4, 2011

Record last verified: 2011-03

Locations

SG (1)