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

NCT04505410 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20200436
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Achieved Clinical Response

  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.

  8 weeks

Secondary Outcomes (2)

• Fecal Calprotectin Levels Measured in Micrograms/Gram

  baseline, 8 weeks

• CRP Levels Measured in mg/dl

  baseline, 8 weeks

Study Arms (2)

Medication plus FMD group

EXPERIMENTAL

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.

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

Medication only group

ACTIVE COMPARATOR

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

Drug: Advanced therapy only without dietary intervention

Interventions

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).

Medication plus FMD group

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).

Medication only group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients younger than 18 years.
• 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

Sponsors & Collaborators

• University of Miami: lead
• Pfizer: collaborator

Study Sites (1)

The University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Limitations and Caveats

First, due to the COVID pandemic, we were unable to reach the recruitment numbers. Another limitation: initial protocol designed to only examine patients initiating tofacitinib but delays in recruitment due to COVID, together with the approval of upadacitinib, led to poor recruitment. Then expanded criteria to include: upadacitinib and to patients initiating their second- or third-line biologic (infliximab, ustekinumab, or risankizumab). Also sample size was small.

Results Point of Contact

• Title: Associate Professor, Director of Translational Studies for the Crohn's and Colitis Center
• Organization: University of Miami Miller School of Medicine

odamas@med.miami.edu

3057733573

Study Officials

• Oriana Damas, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: September 18, 2020
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: February 28, 2025
• Results First Posted: December 30, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)