NCT04505410

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

A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Advanced Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Advanced therapies included will be: JAK inhibitors (tofacitinib or upadacitinib) IL-23 inhibitors (ustekinumab or risankizumab) Anti-TNF (infliximab) Patients will be provided these medications as part of their standard of care, as decided by their treating physician.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-09-18
• Primary completion: 2023-12-07
• Completion: 2023-12-07
• First posted: 2020-08-10
• Last updated: 2025-02-28
• Results posted: 2024-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study