Xeljanz and Healthy Diet

• Status: Recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: All

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 in patients with ulcerative colitis. Study period will be 8 weeks during induction of tofacitinib. 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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Pfizer
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

1. Patients with ulcerative colitis who are beginning tofacitinib therapy.

2. Patients aged 18 years or older.

3. Patients with active disease defined as simple clinical colitis activity index (SCCAI) >2

4. 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