A Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib Induction

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

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.

NCT04505410
Phase

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.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Miami
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

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.

Interventions

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.

The University of Miami, Miami, Florida

Status

Recruiting

Address

The University of Miami

Miami, Florida, 33136

Site Contact

Grechen Mills, BS

gmills@miami.edu

305-243-6405

Gastro Health, Miami, Florida

Status

Not yet recruiting

Address

Gastro Health

Miami, Florida, 33173

Site Contact

Grechen Mills, BS

gmills@miami.edu

305-243-6405

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.

Research