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

University of Miami

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Other: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy; Drug: Advanced therapy only without dietary intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04505410

20200436

Details and patient eligibility

About

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.

Full 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 part of their standard of care, as decided by their treating physician.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Medication plus FMD group

Experimental group

Description:

Participants in this group with UC consuming a standard, regular low-fiber diet will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7.

Treatment:

Other: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy

Medication only group

Active Comparator group

Description:

Participants in this group with UC consuming a diet based on tolerance will start an advanced therapy for eight consecutive weeks.

Treatment:

Drug: Advanced therapy only without dietary intervention