Phase
Condition
Inflammatory Bowel Disease
Ulcers
Crohn's Disease
Treatment
Infliximab induction
Advanced therapy only without dietary intervention
Tofacitinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with ulcerative colitis who are beginning tofacitinib therapy.
Patients with ulcerative colitis who are initiating second line biologic therapywith ustekinumab
Patients with ulcerative colitis who are initiating second line biologic therapywith 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
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 colitisor 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 fastingmimicking diet (see below).
Patients that are diabetics on a glucose lowering drug.
Individuals with a history of syncope/presyncope with fasting or from medicalconditions.
Women who are pregnant or nursing.
Individuals with very low BMI< or equal to 18.
Patients with the following comorbidities: chronic kidney disease, diabetes, activecancer.
Prohibited concomitant therapies will include TNF antagonists, azathioprine,methotrexate, and mercaptopurine.
Patients who routinely have fasting eating habits
Study Design
Study Description
Connect with a study center
Gastro Health
Miami, Florida 33173
United StatesSite Not Available
The University of Miami
Miami, Florida 33136
United StatesSite Not Available
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