Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Miami|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Oriana Damas, MD|
|Principal Investigator Affiliation||University of Miami|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.