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Completed

NCT Number: NCT04505410

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ulcerative colitis who are beginning tofacitinib therapy.
  • Patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab
  • Patients with ulcerative colitis who are initiating second line biologic therapy with infliximab
  • Patients aged 18 years or older.
  • Patients with active disease defined as simple clinical colitis activity index (SCCAI) >2
  • Patients who have not been on antibiotics for 2 weeks or probiotics.

Exclusion criteria

  • Patients younger than 18 years.
  • Patients that do not meet the inclusion criteria specified above.
  • Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis or impending hospitalization for severe ulcerative colitis.
  • Patients with concomitant infectious colitis.
  • Patients allergic nuts/soy/sesame/oats.
  • Patients who do not like the food items that form part of the kits for the fasting mimicking diet (see below).
  • Patients that are diabetics on a glucose lowering drug.
  • Individuals with a history of syncope/presyncope with fasting or from medical conditions.
  • Women who are pregnant or nursing.
  • Individuals with very low BMI< or equal to 18.
  • Patients with the following comorbidities: chronic kidney disease, diabetes, active cancer.
  • Prohibited concomitant therapies will include TNF antagonists, azathioprine, methotrexate, and mercaptopurine.
  • Patients who routinely have fasting eating habits

Treatment and study plan

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

Other

Patients will do two 5-day cycles of a fasting mimicking diet. They will start the first diet cycle 1 week after initiating a new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).

Advanced therapy only without dietary intervention

Drug

Patients in this group will start an advanced therapy and follow a diet solely based on dietary tolerance: new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).

Primary outcomes

  1. Percentage of Patients Who Achieved Clinical Response

    Time frame: 8 weeks

    Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.

Secondary outcomes

  1. Fecal Calprotectin Levels Measured in Micrograms/Gram

    Time frame: baseline, 8 weeks

    Calprotectin levels were evaluated using fecal samples to compare the levels between the treatment and control arms before (baseline) and after the intervention (at 8 weeks). Fecal calprotectin was measured using a BUHLMANN fCAL ELISA Kit. Unit of measure was micrograms/gram.

  2. CRP Levels Measured in mg/dl

    Time frame: baseline, 8 weeks

    Comparison of Median C-Reactive Protein (CRP) levels between the treatment and control arms before (baseline) and after the intervention (at 8 weeks) will be evaluated using blood samples, unit of measure was mg/dl

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Advanced Therapies

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2020
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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