Fast Mimicking Diet for Colitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Colitis+3 More
Fast Mimicking Diet - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether the Fasting Mimicking diet can help improve the effectiveness of tofacitinib or ustekinumab therapy in people with ulcerative colitis, by measuring clinical response and changes in fecal calprotectin and C-reactive protein levels.

Eligible Conditions
  • Colitis
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 8 weeks

8 weeks
Percentage of patients who achieved clinical response
baseline, 8 weeks
Change in CRP levels
Change in Fecal Calprotectin levels

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

6 Treatment Groups

Ustekinumab only
1 of 6
Infliximab only
1 of 6
Tofacitinib only group
1 of 6
Tofacitinib plus FMD group
1 of 6
Infliximab plus FMD group
1 of 6
Ustekinumab plus FMD group
1 of 6

Active Control

Experimental Treatment

76 Total Participants · 6 Treatment Groups

Primary Treatment: Fast Mimicking Diet · No Placebo Group · Phase 3

Tofacitinib plus FMD groupExperimental Group · 2 Interventions: Tofacitinib, Fast Mimicking Diet · Intervention Types: Drug, Other
Infliximab plus FMD groupExperimental Group · 2 Interventions: Fast Mimicking Diet, Infliximab induction · Intervention Types: Other, Drug
Ustekinumab plus FMD groupExperimental Group · 2 Interventions: Fast Mimicking Diet, Ustekinumab induction · Intervention Types: Other, Drug
Ustekinumab only
Drug
ActiveComparator Group · 1 Intervention: Ustekinumab induction · Intervention Types: Drug
Infliximab only
Drug
ActiveComparator Group · 1 Intervention: Infliximab induction · Intervention Types: Drug
Tofacitinib only group
Drug
ActiveComparator Group · 1 Intervention: Tofacitinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of MiamiLead Sponsor
787 Previous Clinical Trials
384,195 Total Patients Enrolled
2 Trials studying Colitis
167 Patients Enrolled for Colitis
PfizerIndustry Sponsor
4,260 Previous Clinical Trials
7,104,919 Total Patients Enrolled
29 Trials studying Colitis
5,370 Patients Enrolled for Colitis
Oriana Damas, MDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with ulcerative colitis who are beginning tofacitinib therapy.
You have active disease defined as simple clinical colitis activity index (SCCAI) >2.
You have not been on antibiotics for 2 weeks or probiotics.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Ontario100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%