Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505410
• Other study ID #: 20200436
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2020
• Est. completion date: December 7, 2023

Study information

• Verified date: December 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.

Drug:
• Ustekinumab induction
Participant will be initiated with ustekinumab induction therapy as second line biologic therapy
• Infliximab induction
Participant will be initiated with infliximab induction therapy as second line biologic therapy

Locations

Country	Name	City	State
United States	The University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who achieved clinical response	Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of =2 points from baseline.	8 weeks
Secondary	Change in Fecal Calprotectin levels	Calprotectin levels will be evaluated using fecal samples	baseline, 8 weeks
Secondary	Change in CRP levels	C-Reactive Protein (CRP) levels will be evaluated using blood samples	baseline, 8 weeks