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Low serine diet for Crohn's Disease (MIM-TESRIC Trial)

N/A

Waitlist Available

Led By Peter D Higgins, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 weeks

Awards & highlights

MIM-TESRIC Trial Summary

This trial is studying whether a low-serine diet can help to reduce symptoms and inflammation in Crohn's disease, as well as improve responses to the biologic therapy Ustekinumab.

MIM-TESRIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The mean simple endoscopic subscore Crohn's disease (SES-CD) score at week 25 between the two treatment groups.

Secondary outcome measures

The mean CD-PRO scores calculated by study team at week 25 will be compared between the two groups with Student's t test.

The mean Crohn's disease patient report outcomes (CD-PRO) score at week 2 will be compared between the two groups with Student's t test

Other outcome measures

The mean C-reactive protein (CRP) at week 2 will be compared between the two groups with Student's t test.

The mean CRP at week 25 will be compared between the two groups with Student's t test.

The mean Crohn's Disease Activity Index (CDAI) scores calculated by study team at week 25 will be compared between the two groups with Student's t test

+6 more

MIM-TESRIC Trial Design

2Treatment groups

Experimental Treatment

Group I: Low serine dietExperimental Treatment1 Intervention

Group II: High serine dietExperimental Treatment1 Intervention

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Who is running the clinical trial?

University of MichiganLead Sponsor

1,795 Previous Clinical Trials

6,373,936 Total Patients Enrolled

Kenneth Rainin FoundationUNKNOWN

Peter D Higgins, MDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still space available for individuals to join this experiment?

"Clinicaltrials.gov shows that this medical trial is accepting participants, having first been posted on March 18th 2021 and last updated May 19th 2022."

Answered by AI

Am I eligible to participate in this experiment?

"This trial is seeking 10 individuals between the ages of 18-70 who are living with ileocolitis to participate."

Answered by AI

Does this research endeavor include participants aged 70 and above?

"This medical study will include those aged 18 and above, with a cut-off of 70 years old."

Answered by AI

What is the maximum capacity of participants for this research trial?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this research endeavour, which was first launched on March 18th 2021, is actively recruiting patients. Specifically, the study seeks 10 individuals from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microbiome Modification to Enhance Stelara Response in Crohn's Disease

Peter Higgins 2021. "Microbiome Modification to Enhance Stelara Response in Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04795960.