Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175292
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2005-09-13
Brief Title:
A Randomized Controlled Trial of VSL3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohns Disease
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohns Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis
Status:
COMPLETED
Status Verified Date:
2008-05
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:
This randomized placebo-controlled double-blind multi-centre trial will determine the efficacy of the probiotic VSL3 in the prevention of Crohns disease development following surgical resection and re-anastomosis A total of 120 patients will be randomly assigned in a 11 ratio to receive VSL3 or placebo for 90 days Patients who respond to study treatment as defined by the absence of a severe endoscopic recurrence at day 90 will be offered open-label VSL3 for an additional 9 months
Detailed Description:
None
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