Status:
WITHDRAWN
Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.
Lead Sponsor:
Mayo Clinic
Conditions:
Ulcerative Colitis
Dietary Modification
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Research of fecal microflora and dysbiosis status in ulcerative colitis (UC) has shown its influential role on the disease pathogenesis. Vedolizumab, a humanized monoclonal antibody blocking the migra...
Detailed Description
Specific Aims: Hypothesis to be investigated: the integrated treatment effect of controlling inflammatory process through vedolizumab in active UC patients can be synergistically enhanced with a stru...
Eligibility Criteria
Inclusion
- 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
- 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:
- Hemoglobin level \<8 g/dL
- WBC count \<3 × 109/L
- Lymphocyte count \<0.5 × 109/L
- Platelet count \<100k/L or \>1200k/L
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN)
- Alkaline phosphatase \>3 × ULN, g) Serum creatinine \>2 × ULN
- Antibiotic use within past 14 days; Probiotics use within past 7 days
Key Trial Info
Start Date :
December 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03309865
Start Date
December 25 2017
End Date
December 31 2018
Last Update
September 26 2018
Active Locations (1)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224