Clinical trial

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

Name

20200436

Description

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.

Trial arms

Trial start

2020-09-18

Estimated PCD

2023-12-07

Trial end

2023-12-07

Status

Completed

Phase

Early phase I

Treatment

Tofacitinib

10mg tofacitinib tablets taken twice daily for eight weeks

Arms:

Tofacitinib only group, Tofacitinib plus FMD group

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.

Arms:

Infliximab plus FMD group, Tofacitinib plus FMD group, Ustekinumab plus FMD group

Ustekinumab induction

Participant will be initiated with ustekinumab induction therapy as second line biologic therapy

Arms:

Ustekinumab only, Ustekinumab plus FMD group

Infliximab induction

Participant will be initiated with infliximab induction therapy as second line biologic therapy

Arms:

Infliximab only, Infliximab plus FMD group

Size

Primary endpoint

Percentage of patients who achieved clinical response

8 weeks

Eligibility criteria

Inclusion Criteria: 1. Patients with ulcerative colitis who are beginning tofacitinib therapy. 2. Patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab 3. Patients with ulcerative colitis who are initiating second line biologic therapy with infliximab 4. Patients aged 18 years or older. 5. Patients with active disease defined as simple clinical colitis activity index (SCCAI) \>2 6. 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

Protocol

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Updated at

2023-12-08

1 organization

3 products

1 indication

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Indication

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