Xeljanz and Healthy Diet

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NCT04505410

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Study Location
The University of Miami
Miami, Florida, 33136, United States
See other locations
Contact
305-243-6405
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

305-243-6405

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

2. Patients aged 18 years or older.

3. Patients with active disease defined as simple clinical colitis activity index (SCCAI) >2

4. Patients who have not been on antibiotics for 2 weeks or probiotics.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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 colitis
or 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 fasting
mimicking 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 medical
conditions.


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, active
cancer.


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


13. Patients who routinely have fasting eating habits

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Advanced Information
Descriptive Information
Brief Title  ICMJE Xeljanz and Healthy Diet
Official Title  ICMJE A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Tofacitinib (Xeljanz) Induction
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 in patients with ulcerative colitis. Study period will be 8 weeks during induction of tofacitinib. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Tofacitinib
    • Other: Fast Mimicking Diet
  • 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.
    Intervention: Drug: Tofacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2020)		76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2023
Estimated Primary Completion Date October 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with ulcerative colitis who are beginning tofacitinib therapy.
  2. Patients aged 18 years or older.
  3. Patients with active disease defined as simple clinical colitis activity index (SCCAI) >2
  4. Patients who have not been on antibiotics for 2 weeks or probiotics.

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 colitis or 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 fasting mimicking 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 medical conditions.
  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, active cancer.
  12. Prohibited concomitant therapies will include TNF antagonists, azathioprine, methotrexate, and mercaptopurine.
  13. Patients who routinely have fasting eating habits
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Grechen Mills, BS305-243-6405[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04505410
Other Study ID Numbers  ICMJE 20200436
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Oriana Mazorra Damas, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Oriana Damas, MDUniversity of Miami
PRS Account University of Miami
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP