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

Last updated: February 14, 2025
Sponsor: University of Miami
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Ulcers

Crohn's Disease

Treatment

Infliximab induction

Advanced therapy only without dietary intervention

Tofacitinib

Clinical Study ID

NCT04505410
20200436
  • Ages > 18
  • All Genders

Study 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 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 Criteria

Inclusion

Inclusion Criteria:

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

  2. Patients with ulcerative colitis who are initiating second line biologic therapywith ustekinumab

  3. Patients with ulcerative colitis who are initiating second line biologic therapywith 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

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 colitisor 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 fastingmimicking 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 medicalconditions.

  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, activecancer.

  12. Prohibited concomitant therapies will include TNF antagonists, azathioprine,methotrexate, and mercaptopurine.

  13. Patients who routinely have fasting eating habits

Study Design

Total Participants: 32
Treatment Group(s): 6
Primary Treatment: Infliximab induction
Phase: 3
Study Start date:
September 18, 2020
Estimated Completion Date:
December 07, 2023

Study 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.

Connect with a study center

  • Gastro Health

    Miami, Florida 33173
    United States

    Site Not Available

  • The University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

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