sing a plant metabolite (quercetin) to optimise medication (mesalazine) metabolism to treat Primary Sclerosing Cholangitis

Phase 1

• Conditions: primary sclerosing cholangitis; inflammatory bowel disease; ulcerative colitis; Oral and Gastrointestinal - Inflammatory bowel disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12619001373167
• Lead Sponsor: IBD Clinical Trials Unit, Mater Research Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-09
• Last Update Posted: 14 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1) Age>18
2) A diagnosis of UC
3) Disease in remission (SCCAI < 3 which is accepted as correlating with remission and has been confirmed in prospective validation cohorts, no specific duration of remission mandated)
4) On 5-ASA therapy, ideally on Mezavant at 4.8 g/day or Pentasa at 4 g/day.

Exclusion Criteria

1) Chronic renal impairment (eGFR< 60)
2) Significant liver disease defined as PSC or elevated liver function tests > 1.5 x upper limit of normal
3) Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites, or
spontaneous hepatic encephalopathy
4) Findings highly suggestive of liver disease of an alternative or concomitant aetiology, including but
not limited to chronic alcoholic liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson’s disease, a1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis
5) Pregnancy or lactation (due to unknown risk profile of quercetin in pregnancy)
6) Active illicit drug or alcohol abuse
7) Need for chronic use of antibiotics
8) History of cholangiocarcinoma, colon cancer
9) History of a colectomy with > 1/3 bowel resected
10) Taking a polyphenol supplement chronically including resveratrol, curcumin, green tea extract,
quercetin
11) Taking an immunosuppressant or biologic for IBD
12) Hypersensitivity to quercetin

Study & Design

• Study Type: Interventional
• Study Design: Not specified