Back to resultsSecond Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tofacitinib
Fast Mimicking Diet
Ustekinumab induction
Infliximab induction
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- The University of MiamiRecruiting
- Gastro Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Tofacitinib plus FMD group
Tofacitinib only group
Infliximab plus FMD group
Infliximab only
Ustekinumab plus FMD group
Ustekinumab only
Arm Description
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.
Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks.
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.
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
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.
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
Outcomes
Primary Outcome Measures
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 ≥2 points from baseline.
Secondary Outcome Measures
Change in Fecal Calprotectin levels
Calprotectin levels will be evaluated using fecal samples
Change in CRP levels
C-Reactive Protein (CRP) levels will be evaluated using blood samples
Full Information
NCT ID
NCT04505410
First Posted
August 5, 2020
Last Updated
September 21, 2023
Sponsor
University of Miami
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT04505410
Brief Title
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tofacitinib plus FMD group
Arm Type
Experimental
Arm Description
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.
Arm Title
Tofacitinib only group
Arm Type
Active Comparator
Arm Description
Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks.
Arm Title
Infliximab plus FMD group
Arm Type
Experimental
Arm Description
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.
Arm Title
Infliximab only
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ustekinumab plus FMD group
Arm Type
Experimental
Arm Description
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.
Arm Title
Ustekinumab only
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Intervention Description
10mg tofacitinib tablets taken twice daily for eight weeks
Intervention Type
Other
Intervention Name(s)
Fast Mimicking Diet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab induction
Intervention Description
Participant will be initiated with ustekinumab induction therapy as second line biologic therapy
Intervention Type
Drug
Intervention Name(s)
Infliximab induction
Intervention Description
Participant will be initiated with infliximab induction therapy as second line biologic therapy
Primary Outcome Measure Information:
Title
Percentage of patients who achieved clinical response
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Fecal Calprotectin levels
Description
Calprotectin levels will be evaluated using fecal samples
Time Frame
baseline, 8 weeks
Title
Change in CRP levels
Description
C-Reactive Protein (CRP) levels will be evaluated using blood samples
Time Frame
baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriella Grau, BS
Phone
305-243-6405
Email
g.grau@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oriana Damas, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Grau, BS
Phone
305-243-6405
Email
g.grau@miami.edu
First Name & Middle Initial & Last Name & Degree
Oriana Damas, MD
Facility Name
Gastro Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Grau
Phone
305-243-6405
Email
g.grau@miami.edu
First Name & Middle Initial & Last Name & Degree
Oriana Damas, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
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