A Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib Induction
NCT04505410
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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.
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.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib Induction | ||||||
Official Title ICMJE | A Randomized Control Study to Examine the Influence of a Fasting Mimicking Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Tofacitinib 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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Oriana Mazorra Damas, University of Miami | ||||||
Study Sponsor ICMJE | University of Miami | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | University of Miami | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |