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
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)|
|Official Title:||A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis.|
|Estimated Study Start Date :||November 25, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
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
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309865
|Contact: Rachel White||(904)firstname.lastname@example.org|
|Principal Investigator:||Ming-Hsi Wang, MD, PhD||Mayo Clinic|