Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513552
Status:
WITHDRAWN
Last Update Posted:
2020-08-20
First Post:
2007-08-06
Brief Title:
Treatment of Crohns Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Treatment of Crohns Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
Status:
WITHDRAWN
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patient
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns disease is a chronic inflammatory disorder of the gastrointestinal tract The origin of Crohns disease remains unknown and there is no curative therapy either medical or surgical for this gut disorder
It is believed that an infectious agent is important in the development of Crohns disease The similarity of Crohns disease to the animal form of ileitis termed Johnes disease supports the possibility that both disorders are caused by exposure to Mycobacterium avium paratuberculosis or MAP Multiple investigators have demonstrated good clinical responses of patients with Crohns disease to treatment with triple antibiotic therapy directed against mycobacterial infection
The hypothesis of this protocol is that triple antibiotic therapy is useful as a medical therapy for patients with Crohns disease The aim of this study is to examine the response of patients with Crohns disease who are not receiving therapy with biological agents to triple antibiotic therapy
It is believed that an infectious agent is important in the development of Crohns disease The similarity of Crohns disease to the animal form of ileitis termed Johnes disease supports the possibility that both disorders are caused by exposure to Mycobacterium avium paratuberculosis or MAP Multiple investigators have demonstrated good clinical responses of patients with Crohns disease to treatment with triple antibiotic therapy directed against mycobacterial infection
The hypothesis of this protocol is that triple antibiotic therapy is useful as a medical therapy for patients with Crohns disease The aim of this study is to examine the response of patients with Crohns disease who are not receiving therapy with biological agents to triple antibiotic therapy
Detailed Description:
Clinical remission will be determined by a decline in the Crohns disease activity index to 151 clinical improvement will be examined using the inflammatory bowel disease IBD quality of life questionnaire and endoscopic improvement will be examined using a Crohns disease endoscopic activity index All individuals must have had colonoscopy within 3 months of enrollment An estimated 20 individuals will be enrolled in this protocol Each patient will be treated for 6 months with a combination of rifabutin clarithromycin and clofazimine At the end of 6 months of treatment for each patient the Crohns disease activity index will be recalculated each patient will again complete the IBD quality of life questionnaire and each patient will undergo repeat colonoscopy
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 |
|---|---|---|---|
| FDA IND 75897 | None | None | None |