Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 tofacitinib therapy or second
line biologic therapy with ustekinumab or infliximab in patients with ulcerative colitis.
Study period will be 8 weeks during induction of tofacitinib or ustekinumab or infliximab.
The primary aims of this study are to determine clinical response and improvement in fecal
calprotectin and C-reactive protein levels. Secondary outcomes will include assessment of
changes in the stool microbiome.
Phase
Phase 3
Funding Agency/Sponsor
Other
Disease
Gastrointestinal, Stomach, Esophageal
Enrollment Eligibility
Inclusion Criteria:
1. Patients with ulcerative colitis who are beginning tofacitinib therapy.
2. Patients with ulcerative colitis who are initiating second line biologic therapy with
ustekinumab
3. Patients with ulcerative colitis who are initiating second line biologic therapy with
infliximab
4. Patients aged 18 years or older.
5. Patients with active disease defined as simple clinical colitis activity index (SCCAI)
>2
6. Patients who have not been on antibiotics for 2 weeks or probiotics.
Exclusion Criteria:
1. Patients younger than 18 years.
2. Patients that do not meet the inclusion criteria specified above.
3. Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis
or impending hospitalization for severe ulcerative colitis.
4. Patients with concomitant infectious colitis.
5. Patients allergic nuts/soy/sesame/oats.
6. Patients who do not like the food items that form part of the kits for the fasting
mimicking diet (see below).
7. Patients that are diabetics on a glucose lowering drug.
8. Individuals with a history of syncope/presyncope with fasting or from medical
conditions.
9. Women who are pregnant or nursing.
10. Individuals with very low BMI< or equal to 18.
11. Patients with the following comorbidities: chronic kidney disease, diabetes, active
cancer.
12. Prohibited concomitant therapies will include TNF antagonists, azathioprine,
methotrexate, and mercaptopurine.
13. Patients who routinely have fasting eating habits