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

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04505410

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arms

34.9

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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 tofacitinib therapy or second line biologic therapy with ustekinumab or infliximab in patients with ulcerative colitis. Study period will be 8 weeks during induction of tofacitinib or ustekinumab or infliximab. The primary aims of this study are to determine clinical response and improvement in fecal calprotectin and C-reactive protein levels. Secondary outcomes will include assessment of changes in the stool microbiome.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Tofacitinib Other: Fast Mimicking Diet Drug: Ustekinumab induction Drug: Infliximab induction	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official 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 Biological Medications Tofacitinib, Ustekinumab or Vedolizumab

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tofacitinib plus FMD group Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.	Drug: Tofacitinib 10mg tofacitinib tablets taken twice daily for eight weeks Other: Fast Mimicking Diet FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
Active Comparator: Tofacitinib only group Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks.	Drug: Tofacitinib 10mg tofacitinib tablets taken twice daily for eight weeks
Experimental: Infliximab plus FMD group Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with infliximab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.	Other: Fast Mimicking Diet FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients. Drug: Infliximab induction Participant will be initiated with infliximab induction therapy as second line biologic therapy
Active Comparator: Infliximab only Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with infliximab	Drug: Infliximab induction Participant will be initiated with infliximab induction therapy as second line biologic therapy
Experimental: Ustekinumab plus FMD group Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with ustekinumab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.	Other: Fast Mimicking Diet FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients. Drug: Ustekinumab induction Participant will be initiated with ustekinumab induction therapy as second line biologic therapy
Active Comparator: Ustekinumab only Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with ustekinumab	Drug: Ustekinumab induction Participant will be initiated with ustekinumab induction therapy as second line biologic therapy

Outcome Measures

Primary Outcome Measures

Percentage of patients who achieved clinical response [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 ≥2 points from baseline.

Secondary Outcome Measures

Change in Fecal Calprotectin levels [baseline, 8 weeks]
Calprotectin levels will be evaluated using fecal samples
Change in CRP levels [baseline, 8 weeks]
C-Reactive Protein (CRP) levels will be evaluated using blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Miami	Miami	Florida	United States	33136
2	Gastro Health	Miami	Florida	United States	33173

Sponsors and Collaborators

University of Miami
Pfizer

Investigators

Principal Investigator: Oriana Damas, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oriana Mazorra Damas, Assistant Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04505410

Other Study ID Numbers:

20200436

First Posted:

Aug 10, 2020

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022