NCT03309865

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

Withdrawn EARLY_PHASE1 Last updated 26 September 2018

What this trial tests

EARLY_PHASE1 trial testing semi-vegetarian diet in Ulcerative Colitis. Withdrawn.

Timeline

25 December 2017

Primary endpoint
31 August 2018

31 December 2018

Quick facts

Lead sponsor	Mayo Clinic
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	25 December 2017
Primary completion	31 August 2018
Estimated completion	31 December 2018
Sites	1 location across United States

Drugs / interventions tested

• semi-vegetarian diet
• Vedolizumab Injection

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• Dietary Modification — all drugs for Dietary Modification →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Ulcerative Colitis or Dietary Modification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advanced Combination Treatment With Biologic Agents and Novel Small Molecule Drugs for Inflammatory Bowel Disease.
   Solitano V, Ma C, Hanžel J, Panaccione R, et al · · 2023 · cited 23× · PMID 37799456