Clinical trial of oral treatment for ulcerative colitis

University of the Sunshine Coast

USC Clinical Trials is continuing early-phase research into an investigational treatment that aims to improve the lives of those with mild to moderate ulcerative colitis by reducing inflammation and improving the gut's healing ability.

Ulcerative colitis is a condition that causes chronic inflammation on the surface

of the colon, the largest part of the large intestine, which can lead to episodes of

bloody diarrhoea, stool urgency and abdominal pain.

USC Clinical Trials Director Lucas Litewka said Australia's prevalence of ulcerative

colitis and Crohn's disease (another condition involving intestinal inflammation)

were among the highest in the world.

"Our partnership with Sunshine Coast gastroenterologists has taught us that the

incidence of ulcerative colitis is also quite high in this region," Mr Litewka said.

"So it makes sense that we continue to offer new clinical trial investigational

treatment options for patients with this condition."

Associate Professor Sue Thackwray and local gastroenterologists are supervising

the study, which is being conducted at USC Clinical Trials' centre at Sippy Downs.

"There is an ongoing unmet medical need for an oral ulcerative colitis treatment

that is effective in achieving long-term remission and mucosal healing with

limited side effects," Dr Thackwray said.

"While it remains to be seen by conducting this Phase 2 ulcerative colitis trial, this study is a novel gut-targeted investigational treatment for ulcerative colitis that might fit the bill."

Adults aged over 18 with a documented diagnosis of active mild to moderate

ulcerative colitis, who have not received treatment with a biologic therapy (such

as Humira or Remicade) and are willing to undergo further colonoscopies can

take part in the trial.

It will run for a 36-week placebo-controlled period (10 visits) with the option to

roll on to a 24-week open-label extension period (seven visits) at the USC Clinical

Trials centre.

Those who meet the eligibility criteria and are enrolled in the study will be

reimbursed for their time and travel expenses. Patients interested in

participating can register their interest at www.usc.edu.au/trials or (07) 5456 3797.

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