Trial Details

Not Recruiting
Basic Information
Clinical ID c2612
Identifier ACTRN12619001373167
Trial Title Quercetin as an Adjunct to Primary Sclerosing Cholangitis Therapy with 5-ASA through Inhibition of N-acetylation__
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions primary sclerosing cholangitis;inflammatory bowel disease;ulcerative colitis; 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
Interventions Pharmacokinetic Pilot Study Mesalazine (5-ASA) is an effective first-line therapy for patients with UC however there are no reports, positive or negative, of efficacy in PSC. 5-ASA is known to be rapidly N-acetylated once it is absorbed in the colon and released into the blood. N-acetylation inactivates 5-ASA, likely negating its effect before it reaches the biliary duct. Some 5-ASA escapes the intestine without being metabolized and is subsequently acetylated in the liver. The enzyme responsible for the N-acetylation is N- acetyltransferase 1, or NAT-1. NAT-1 is present in the lining of the intestine as well as in the liver. Quercetin is a flavonoid found in fruits and vegetables that has been shown to inhibit NAT-1. Quercetin was reviewed by the Food and Drug Administration (FDA) in 2010 and was given enerally recognised as safe(GRAS) designation at a dose of 1500mg/d. We propose that 5-ASA may be an effective therapy for primary sclerosing cholangitis (PSC). However, 5-ASA is metabolized to an inactive form preventing active 5-ASA to be able exert a therapeutic effect on the liver and biliary tree in PSC. Quercetin has been shown to inhibit N-acetyl transferase 1, the enzyme that metabolizes 5-ASA. Quercetin may also be therapeutic in PSC based on its anti-inflammatory properties. This pilot study aims to test if quercetin has a therapeutic potential in PSC by inhibiting NAT-1 and delivering active 5-ASA at a higher concentration to the liver. If successful, subsequent studies will examine its therapeutic potential in PSC. Participants already taking 5-ASA (4g daily, oral tablets or granules) will be enrolled. After the initial visit for screening and consent, participants will be instructed to continue their oral 5-ASA 4g tablets or granules, once a day in the morning before food. For baseline results without quercetin supplmentation, participants will return to the study centre on day 7 after continuing their prescribed
Participant Information
Sponsor IBD Clinical Trials Unit, Mater Research Ltd.
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase EARLY_PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -