Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03309865
• Date of registration: 07/10/2017
• Prospective Registration: Yes
• Primary sponsor: Mayo Clinic
• Public title: Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.
• Scientific title: A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis.
• Date of first enrolment: December 25, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03309865
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Ming-Hsi Wang, MD, PhD
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years or older

- diagnosed with active UC (with a Mayo score =4, with an endoscopic Mayo Clinic score
=1, and disease that extended 15 cm or more from the anal verge)

- failed with prior mesalamine therapy

- Patients who were previously exposed to mesalamine or steroids will have a 30-day
washout period before being enrolled

- Patients who were previously exposed to tumor necrosis factor (TNF) antagonists will
have a 60-day washout period before being enrolled

- For patients who were previously exposed to glucocorticoids, immunosuppressive
medications (i.e., azathioprine, 6-mercaptopurine, or methotrexate), or TNF
antagonists, a documentation of unsuccessful previous treatment (i.e., lack of
response or unacceptable adverse events) is required

- A diagnosis of UC confirmed by biopsy obtained at the index colonoscopy or flexible
sigmoidoscopy.

Exclusion Criteria:

- Patients who have been on semi-vegetarian diet before the trial will be excluded

- pregnancy or lactation

- an unstable or uncontrolled medical disorder

- an anticipated requirement for major surgery

- history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
Koch pouch, or ileostomy for UC, or planned bowel surgery

- unable to give informed consent

- current diagnosis of fulminant colitis or toxic megacolon, abdominal abscess,
symptomatic colonic stricture, stoma

- disease limited to the rectum (ulcerative proctitis)

- current total parenteral nutrition

- positive Clostridium difficile stool assay

- history of an infection requiring intravenous antimicrobial therapy within 1 month or
oral antimicrobial therapy within 2 weeks

- history of listeria, histoplasmosis, chronic or active hepatitis B or C infection,
human immunodeficiency virus, immunodeficiency syndrome, untreated tuberculosis

- history of central nervous system demyelinating disease

- history of malignancy other than a successfully treated nonmetastatic cutaneous
squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix, or
evidence of dysplasia or malignancy on the screening colonoscopy/flexible
sigmoidoscopy with biopsy

- Any of the following laboratory abnormalities during the screening period:

1. Hemoglobin level <8 g/dL

2. WBC count <3 × 109/L

3. Lymphocyte count <0.5 × 109/L

4. Platelet count <100k/L or >1200k/L

5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper
limit of normal (ULN)

6. Alkaline phosphatase >3 × ULN, g) Serum creatinine >2 × ULN

- Antibiotic use within past 14 days; Probiotics use within past 7 days



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dietary Modification

Ulcerative Colitis

Intervention(s)

Dietary Supplement: semi-vegetarian diet

Drug: Vedolizumab Injection

Primary Outcome(s)

Clinical response at week 6 [Time Frame: 6 weeks]

Secondary Outcome(s)

Clinical response at week 14 [Time Frame: 14 weeks]

Secondary ID(s)

IRB 17-005613

Source(s) of Monetary Support

Please refer to primary and secondary sponsors