Microbiome Modification to Enhance Stelara Response in Crohn's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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)...
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.
Tracking Information
- NCT #
- NCT04795960
- Collaborators
- Kenneth Rainin Foundation
- Investigators
- Principal Investigator: Peter D Higgins, MD University of Michigan