Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 18, 2020

Primary Completion Date

December 7, 2023

Study Completion Date

December 7, 2023

Conditions
Ulcerative Colitis
Interventions
OTHER

"A plant based high fiber diet that mimics fasting (FMD) plus advanced therapy"

Patients will do two 5-day cycles of a fasting mimicking diet. They will start the first diet cycle 1 week after initiating a new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).

DRUG

Advanced therapy only without dietary intervention

Patients in this group will start an advanced therapy and follow a diet solely based on dietary tolerance: new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).

Trial Locations (1)

33136

The University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

University of Miami

OTHER

NCT04505410 - Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis | Biotech Hunter | Biotech Hunter