A Study of the Effect of Vedolizumab in Conjunction with Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 17-005613
    Sponsor Protocol Number: 17-005613

About this study

The purpose of this study is to assess the integrated effect of normalization of intestinal dysbiosis through a structured semi-vegetarian dietary intervention in active UC patients who will also be under the standard of care medical therapy (vedolizumab).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 18 years or older diagnosed with active ulcerative colitis (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) who had failed with 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 ulcerative colitis (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. 
  • Other criteria include:
    • 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  
    • Planned bowel surgery
  • Unable to give informed consent
  • Unable to swallow pills/capsules 
  • 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 
  • Evidence of dysplasia or malignancy on the screening colonoscopy/flexible sigmoidoscopy with biopsy  
  • Any of the following laboratory abnormalities during the screening period: a) Hemoglobin level <8 g/dL, b) WBC count <3 × 109/L, c) Lymphocyte count <0.5 × 109/L, d) Platelet count <100k/L or >1200k/L, e) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN), f) Alkaline phosphatase >3 × ULN, g) Serum creatinine >2 × ULN
  • Antibiotic use within past 14 days 
  • Probiotics use within past 7 days

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Ming-Hsi Wang, M.D., Ph.D.

Contact us for the latest status

Contact information:

Rachel White

(904)953-8513

White.Rachel2@mayo.edu