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
Overview
- Phase
- Phase 3
- Intervention
- A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy
- Conditions
- Ulcerative Colitis
- Sponsor
- University of Miami
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Who Achieved Clinical Response
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Oriana Mazorra Damas
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Patients with ulcerative colitis who are beginning tofacitinib therapy.
- •Patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab
- •Patients with ulcerative colitis who are initiating second line biologic therapy with infliximab
- •Patients aged 18 years or older.
- •Patients with active disease defined as simple clinical colitis activity index (SCCAI) \>2
- •Patients who have not been on antibiotics for 2 weeks or probiotics.
Exclusion Criteria
- •Patients younger than 18 years.
- •Patients that do not meet the inclusion criteria specified above.
- •Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis or impending hospitalization for severe ulcerative colitis.
- •Patients with concomitant infectious colitis.
- •Patients allergic nuts/soy/sesame/oats.
- •Patients who do not like the food items that form part of the kits for the fasting mimicking diet (see below).
- •Patients that are diabetics on a glucose lowering drug.
- •Individuals with a history of syncope/presyncope with fasting or from medical conditions.
- •Women who are pregnant or nursing.
- •Individuals with very low BMI\< or equal to
Arms & Interventions
Medication plus FMD group
Participants in this group with UC consuming a standard, regular low-fiber diet will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7.
Intervention: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy
Medication only group
Participants in this group with UC consuming a diet based on tolerance will start an advanced therapy for eight consecutive weeks.
Intervention: Advanced therapy only without dietary intervention
Outcomes
Primary Outcomes
Percentage of Patients Who Achieved Clinical Response
Time Frame: 8 weeks
Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.
Secondary Outcomes
- Fecal Calprotectin Levels Measured in Micrograms/Gram(baseline, 8 weeks)
- CRP Levels Measured in mg/dl(baseline, 8 weeks)