Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.
Status:
Withdrawn
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
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).