drugset / Trial / NCT04505410

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

NCT04505410

Phase 3 Completed 32 enrolled University of Miami Pfizer · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. The primary aims of this study will be clinical response, as determined by the simple clinical colitis activity index (SCCAI). Secondary outcomes will be improvement in fecal calprotectin and C-reactive protein levels.

Timeline

Start
2020-09-18
Primary completion
2023-12-07
Completion
2023-12-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Infliximab Monoclonal antibody
Comparator Risankizumab Monoclonal antibody
Comparator Tofacitinib Small molecule
Comparator Upadacitinib Small molecule
Comparator Ustekinumab Monoclonal antibody

Indications