Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305409
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2006-03-20
Brief Title:
Synbiotic Treatment in Crohns Disease Patients
Sponsor:
University of Dundee
Organization:
University of Dundee
Study Overview
Official Title:
Synbiotic Treatment in Crohns Disease Patients
Status:
COMPLETED
Status Verified Date:
2009-02
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 purpose of this study is to determine whether administration of a synbiotic comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohns patients with active disease to reduce mucosal inflammation and induce remission
Detailed Description:
Crohns disease is one of the two main forms of idiopathic inflammatory bowel disease The Th1-mediated inflammatory response in Crohns disease is characterised by increased IL-18 and INF-gamma and especially TNF-alpha which are formed by lamina propria mononuclear cells The aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic that we have previously shown to down-regulate TNF-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease can colonise the bowel wall reduce mucosal inflammation and induce remission in Crohns disease patients with active disease in a randomised controlled trial Crohns disease is associated with high mortality and incurs significant social commercial and NHS costs Many patients are refractile to standard treatments which often have undesirable side effects An inexpensive effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LREC Ref 0551401111 | None | None | None |
| RND ID 2004GA07 | None | None | None |