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Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis

CompletedPhase 3

Sponsor: University of Miami

Conditions: Ulcerative Colitis

Interventions: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy, Advanced therapy only without dietary intervention

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Miami, Florida, United States