Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631586
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Standardized Microbiota Transplant Therapy in Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Standardized Microbiota Transplant Therapy in Crohns Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns disease CD develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract Current drug therapies for CD are directed at the immune system The emergence of fecal microbiota transplantation FMT for the treatment of recurrent C difficile infections rCDI has opened a frontier of restorative therapies targeting the gut microbiome This study aims to assess if two forms of encapsulated FMT material MTP101C and MTP101S can effectively engraft in the ileum and colon of individuals with CD This study will also assess how the impact of CD phenotype impacts engraftment Finally this study will explore symptom and endoscopic changes before and after these two therapies
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