Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:30 AM
Study NCT ID:
NCT04795960
Status:
WITHDRAWN
Last Update Posted:
2023-06-12
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome Modification to Enhance Stelara Response in Crohn's Disease
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Microbiome Modification to Enhance Stelara Response in Crohn's Disease
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of eligible and interested patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIM-TESRIC
Brief Summary:
This pilot study is being completed to determine whether a low-serine diet vs a high serine diet will reduce inflammation and symptoms in Crohn's disease (CD), as well as determine whether a low-serine diet (vs. a high serine diet) will improve responses in patients initiating therapy with Ustekinumab (Stelara), an FDA-approved biologic therapy for Crohn's disease.
Detailed Description:
Eligible participants that will be given Ustekinumab as part of their standard of care will be enrolled in this study.
The study hypotheses include that a low serine diet (compared to a high serine diet) in patients with active CD will:
* Reduce the relative abundance of Adherent invasive ecoli (AIEC), and increase the relative abundance of Bacteroides and Faecalibacterium in stool of patients with Crohn's disease.
* Make patients more likely to respond to ustekinumab (anti-Interleukin12/23) therapy with control of inflammation as measured by the mean Simple endoscopic subscore Crohn's disease (SES-CD) in each group at week 25.
The study hypotheses include that a low serine diet (compared to a high serine diet) in patients with active CD will:
* Reduce the relative abundance of Adherent invasive ecoli (AIEC), and increase the relative abundance of Bacteroides and Faecalibacterium in stool of patients with Crohn's disease.
* Make patients more likely to respond to ustekinumab (anti-Interleukin12/23) therapy with control of inflammation as measured by the mean Simple endoscopic subscore Crohn's disease (SES-CD) in each group at week 25.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: