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

Sponsor

National University Hospital, Singapore (Other)

Overall Status

Completed

CT.gov ID

NCT00786123

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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 Names: 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

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 Names:

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

Outcome Measures

Primary Outcome Measures

Resolution of symptoms [6 weeks]

Secondary Outcome Measures

Rectal sensitivity [6 weeks]
Saliva and fecal melatonin levels [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.