Status:
COMPLETED
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 18.
- Patients with the following comorbidities: chronic kidney disease, diabetes, active cancer.
- Prohibited concomitant therapies will include TNF antagonists, azathioprine, methotrexate, and mercaptopurine.
- Patients who routinely have fasting eating habits
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04505410
Start Date
September 18 2020
End Date
December 7 2023
Last Update
February 28 2025
Active Locations (1)
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1
The University of Miami
Miami, Florida, United States, 33136