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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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: 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 V: 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 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
911 Previous Clinical Trials
411,161 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
218 Patients Enrolled for Ulcerative Colitis
PfizerIndustry Sponsor
4,580 Previous Clinical Trials
14,634,171 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
426,002 Patients Enrolled for Ulcerative Colitis
Oriana Damas, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have active disease defined as simple clinical colitis activity index (SCCAI) >2.You have certain medical conditions such as ongoing kidney disease, diabetes, or current cancer.You have a body mass index (BMI) of 18 or below, which is considered very low.You have ulcerative colitis and are about to start taking tofacitinib.You have ulcerative colitis and are starting a new biologic treatment called ustekinumab as a second option.You don't like the food that is included in the fasting mimicking diet kit.You have an allergy to nuts, soy, sesame, or oats.You have not taken antibiotics or probiotics in the past two weeks.You have a history of fainting or feeling like you might faint due to fasting or medical conditions.You do not meet the requirements to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Infliximab only
- Group 2: Tofacitinib plus FMD group
- Group 3: Ustekinumab only
- Group 4: Infliximab plus FMD group
- Group 5: Ustekinumab plus FMD group
- Group 6: Tofacitinib only group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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