At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy and Advanced therapy only without dietary intervention for Ulcerative Colitis. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
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).