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Trial record 2 of 72 for:    vedolizumab

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

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ClinicalTrials.gov Identifier: NCT03309865
Recruitment Status : Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Ming-Hsi Wang, Mayo Clinic

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 migration of leukocytes into inflamed intestinal tissue, has been shown to achieve remission in about half of active UC patients. Dietary intervention in UC patients has not been adequately studied. There is a significant clinical gap to achieve a higher efficacy and better clinical outcomes on the treatment of active UC patients. This study proposes 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).

Significance of investigation for innovation: The pathogenesis of UC has been found to be multi-factorial, including host genetics and dysregulated inflammatory response, and recent research has shown the influential role of gut environmental factors - dysbiosis which has been found the key feature of UC. Vedolizumab has been shown effective (e.g. 47% clinical response rate vs. 25% in placebo group) and is part of the current standard of care treatment in UC. With the observation of drastic increase of IBD patients in Asia, in which has historically low incidence of IBD, it is generally accepted that the westernized diet and urbanization of life style play an important role in IBD pathogenesis. Enteral nutritional therapy has been demonstrated effective in pediatric Crohn's disease (CD) patients; however, the application to adult IBD patients has not been widely accepted partly because of the compliance issue. In addition, unlike CD, neither enteral nutrition nor non-enteral nutrition in patients with active UC has been adequately studied. Therefore, this study proposes a novel approach to assess the integrated effect of a structured dietary intervention in active UC patients who will also be under the current standard of care medical therapy (vedolizumab). After this study achieves the proposed primary or secondary outcome, it will further support the hypothesized synergistic interactive therapeutic effect between the normalization of dysbiosis in the intestine (through dietary intervention) and anti-inflammatory biologics (vedolizumab).


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Modification Dietary Supplement: semi-vegetarian diet Drug: Vedolizumab Injection Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis.
Anticipated Study Start Date : November 25, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Combined diet and vedolizumab
Intervention: vedolizumab injection (300mg, IV infusions at week 0, 2, 6, 14) and concurrently on structured semi-vegetarian diet; Duration of Therapy: 14 weeks
Dietary Supplement: semi-vegetarian diet
semi-vegetarian dietary intervention: Duration of Therapy: 14 weeks;
Drug: Vedolizumab Injection
vedolizumab (300mg) IV infusions at week 0, 2, 6, 14; Duration of Therapy: 14 weeks
Other Name: vedolizumab



Primary Outcome Measures :
  1. Clinical response at week 6 [ Time Frame: 6 weeks ]
    Clinical response at week 6 (which is defined as ≥3 improvement in Mayo score, and a decrease of at least 30% from the baseline score).


Secondary Outcome Measures :
  1. Clinical response at week 14 [ Time Frame: 14 weeks ]
    Clinical response at week 14(which is defined as ≥3 improvement in Mayo score, and a decrease of at least 30% from the baseline score).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309865


Contacts
Contact: Rachel White (904)953-8513 white.rachel2@mayo.edu

Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ming-Hsi Wang, MD, PhD Mayo Clinic

Responsible Party: Ming-Hsi Wang, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03309865     History of Changes
Other Study ID Numbers: IRB 17-005613
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ming-Hsi Wang, Mayo Clinic:
semi-vegetarian diet
vedolizumab
ulcerative colitis

Additional relevant MeSH terms:
Vedolizumab
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Gastrointestinal Agents