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Monoclonal Antibodies

Induction Therapy + Healthy Diet for Ulcerative Colitis

Phase 3
Waitlist Available
Led By Oriana Damas, MD
Research Sponsored by University of Miami
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 8 weeks
Awards & highlights

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
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Percentage of patients who achieved clinical response
Secondary outcome measures
Change in CRP levels
Change in Fecal Calprotectin levels

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Ustekinumab plus FMD groupExperimental Treatment2 Interventions
Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with ustekinumab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Group II: Tofacitinib plus FMD groupExperimental Treatment2 Interventions
Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Group III: Infliximab plus FMD groupExperimental Treatment2 Interventions
Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with infliximab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Group IV: Ustekinumab onlyActive Control1 Intervention
Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with ustekinumab
Group V: Infliximab onlyActive Control1 Intervention
Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with infliximab
Group VI: Tofacitinib only groupActive Control1 Intervention
Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 3
~39970
Ustekinumab induction
2020
Completed Phase 3
~40
Infliximab induction
2020
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
898 Previous Clinical Trials
409,619 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
218 Patients Enrolled for Ulcerative Colitis
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,841 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
425,987 Patients Enrolled for Ulcerative Colitis
Oriana Damas, MDPrincipal InvestigatorUniversity of Miami

Media Library

Infliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04505410 — Phase 3
Ulcerative Colitis Research Study Groups: Tofacitinib plus FMD group, Ustekinumab only, Infliximab only, Infliximab plus FMD group, Ustekinumab plus FMD group, Tofacitinib only group
Ulcerative Colitis Clinical Trial 2023: Infliximab Highlights & Side Effects. Trial Name: NCT04505410 — Phase 3
Infliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505410 — Phase 3

Frequently Asked Questions

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

Are people still being recruited for this research project?

"The trial, which can be found on clinicaltrials.gov, is currently looking for patients to participate. This particular study was originally posted on November 18th 2020 and the listing was last edited on April 22nd 2022."

Answered by AI

What is the FDA's stance on Fast Mimicking Diet?

"There is already some evidence for the efficacy of Fast Mimicking Diet, as well as several rounds of data supporting its safety. Thus, it received a score of 3."

Answered by AI

Which maladies have been shown to respond most favorably to the Fast Mimicking Diet?

"While often used to treat juvenile arthritis, Fast Mimicking Diet can also be employed when other treatments like methotrexate prove intolerant or ineffective."

Answered by AI

What other scientific investigations have included a Fast Mimicking Diet?

"As of right now, there are a total of 34 ongoing clinical trials related to the Fast Mimicking Diet. Out of these active studies, 7 are in Phase 3. The many trials for this treatment originate from Shanghai, but there are 656 locations running studies worldwide."

Answered by AI

How many people can join this research project at the most?

"Yes, the information on clinicaltrials.gov indicates that this trial is currently recruiting patients. The trial was first posted on November 18th 2020 and was last updated on April 22nd 2022. The study is looking for 76 patients at 2 sites."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
Oriana Mazorra Damas 2020. "Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505410.
~7 spots leftby Apr 2025
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