Microbiome Modification to Enhance Stelara Response in Crohn's Disease — MIM-TESRIC  

Crohn Disease Clinical Trial

Official title: Microbiome Modification to Enhance Stelara Response in Crohn's Disease

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT04795960
• Study type: Interventional
• Source: University of Michigan
• Status: Withdrawn
• Phase: N/A
• Start date: March 18, 2021
• Completion date: March 2023