Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114465
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2005-06-14
Brief Title:
VSL3 Versus Placebo in Maintenance of Remission in Crohns Disease
Sponsor:
Orphan Australia
Organization:
Orphan Australia
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Study of VSL3 Versus Placebo in the Maintenance of Remission in Crohns Disease
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to compare the efficacy of the probiotic VSL3 versus placebo in addition to standard maintenance drugs in maintaining remission in Crohns disease CD
The secondary objectives are
To determine the time till flare of CD patients on VSL3 compared to placebo
To assess whether concurrent therapy with VSL3 leads to an improvement in the quality of life QOL
To assess whether concurrent therapy with VSL3 reduces the severity of a flare if it occurs
The secondary objectives are
To determine the time till flare of CD patients on VSL3 compared to placebo
To assess whether concurrent therapy with VSL3 leads to an improvement in the quality of life QOL
To assess whether concurrent therapy with VSL3 reduces the severity of a flare if it occurs
Detailed Description:
Advancing knowledge regarding the biology of Crohns Disease CD has identified that the hosts innate immunity may impact on the development of intestinal inflammation Pattern recognition receptors and the Toll-like receptors are able to detect both gram positive and gram negative bacteria yeasts and flagellin and respond by activation of the innate immune system By identification of the unmethylated CpG dinucleotide sequences found in bacteria lymphocytes are stimulated proinflammatory cytokines like interleukin IL-12 and the interferons are induced and both the mucosal and host defences against the invading pathogens are increased
A body of evidence from clinical and experimental observations indicates a role for endogenous digestive microflora in the pathogenesis of inflammatory bowel disease IBD The distal ileum and the colon are the areas with highest luminal bacterial concentrations and represent the sites of inflammation in IBD Probiotics have been shown to reduce intestinal inflammation in animal studies In the human probiotics may also reduce inflammation particularly in Crohns disease CD and ulcerative colitis UC Probiotics are effective in the treatment of acute pouchitis and its prevention Their use also appears to have some effect in the management of active intestinal inflammation in UC and preliminary results suggest a role in the maintenance of remission
NOD-2CARD-15 is a gene that identifies colonic bacteria and can activate the NF-kb pathway in order to destroy the invading bacteria The identification that mutation of the NOD-2CARD-15 gene increases a persons susceptibility to developing CD suggests that a defect in the innate immunity may impact on the development of the chronic intestinal inflammation CD patients are also more likely to have an increase in the mucosal permeability thus allowing colonic bacteria to cross into the mucosal layer A central role for the colonic bacteria would thus appear to be possible in the development and maintenance of intestinal inflammation and thus the potential effects and benefits of probiotics in the management of CD requires further investigation
It appears that treatment with high-potency probiotic preparations for oral bacteriotherapy may enhance the concentrations of protective bacteria of the endogenous digestive microflora and therefore may provide a therapeutic benefit in patients with CD
This is a phase IV multicentre randomised double-blind placebo-controlled trial of VSL3 versus placebo in the maintenance of remission in patients with CD The patients will be randomised to a treatment group receiving one sachet of VSL3 twice a day and a group receiving the placebo drug in one sachet twice a day The patients are assessed at baseline and every 12 weeks until the completion of the study at 52 weeks At every visit the patient will have routine blood tests for CD a physical examination and questionnaire will be applied
A body of evidence from clinical and experimental observations indicates a role for endogenous digestive microflora in the pathogenesis of inflammatory bowel disease IBD The distal ileum and the colon are the areas with highest luminal bacterial concentrations and represent the sites of inflammation in IBD Probiotics have been shown to reduce intestinal inflammation in animal studies In the human probiotics may also reduce inflammation particularly in Crohns disease CD and ulcerative colitis UC Probiotics are effective in the treatment of acute pouchitis and its prevention Their use also appears to have some effect in the management of active intestinal inflammation in UC and preliminary results suggest a role in the maintenance of remission
NOD-2CARD-15 is a gene that identifies colonic bacteria and can activate the NF-kb pathway in order to destroy the invading bacteria The identification that mutation of the NOD-2CARD-15 gene increases a persons susceptibility to developing CD suggests that a defect in the innate immunity may impact on the development of the chronic intestinal inflammation CD patients are also more likely to have an increase in the mucosal permeability thus allowing colonic bacteria to cross into the mucosal layer A central role for the colonic bacteria would thus appear to be possible in the development and maintenance of intestinal inflammation and thus the potential effects and benefits of probiotics in the management of CD requires further investigation
It appears that treatment with high-potency probiotic preparations for oral bacteriotherapy may enhance the concentrations of protective bacteria of the endogenous digestive microflora and therefore may provide a therapeutic benefit in patients with CD
This is a phase IV multicentre randomised double-blind placebo-controlled trial of VSL3 versus placebo in the maintenance of remission in patients with CD The patients will be randomised to a treatment group receiving one sachet of VSL3 twice a day and a group receiving the placebo drug in one sachet twice a day The patients are assessed at baseline and every 12 weeks until the completion of the study at 52 weeks At every visit the patient will have routine blood tests for CD a physical examination and questionnaire will be applied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None