drugset / Trial / NCT04505410
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infliximab | Monoclonal antibody | — | — |
| Comparator | Risankizumab | Monoclonal antibody | — | — |
| Comparator | Tofacitinib | Small molecule | — | — |
| Comparator | Upadacitinib | Small molecule | — | — |
| Comparator | Ustekinumab | Monoclonal antibody | — | — |