Evaluation of indomethacin challenge on intestinal permeability
Research type
Research Study
Full title
A three-period cross-over study to evaluate the effect of an indomethacin challenge on intestinal permeability using sugar probes in healthy male and female participants aged 18 to 60 years.
IRAS ID
316973
Contact name
Ugochukwu Stephanie Igwe
Contact email
Sponsor organisation
GlaxoSmithKline
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Patients with bowel diseases have been found to have a gut (small intestine and colon) that is ‘leaky’ and allows substances to pass through more easily. This study aims to understand whether administering indomethacin to healthy volunteers can cause reproducible changes in the ability of substances to pass through the gut, which could be used to assess medicines that will reduce gut leakiness for future treatment of patients with bowel diseases.
Changes in gut leakiness will be assessed using a mixture of 4 sugars which volunteers will drink and then measuring them in blood and urine over 24 hours. Volunteers will have their sugar levels assessed after being given indomethacin or placebo (a dummy tablet). As there is natural variability in volunteers’ gut’s ability to allow substances to pass through it, the measurements will be taken more than once, to inform if the measurements can be repeated.
Approximately 30 healthy male and female adults aged between 18 and 60 years will be included in the study.
The study will consist of 3 periods, each volunteer will be randomly allocated to a sequence so they receive indomethacin and placebo at least once as well as a repeat of either indomethacin or placebo. The study doctor and the volunteers will be blinded to the treatments given at each period.
The study will involve the following periods
• A screening period 28 days before the first dose
• 3 study periods including 2 nights stay at the clinical unit during each period
• A washout of 7-21 days between each period
• A follow-up phone call 5-9 days after the last study drug administration.
The study will be conducted in an MHRA accredited clinical research unit in the UK with appropriate medical and safety monitoring for all the volunteers taking part in the study.REC name
London - Riverside Research Ethics Committee
REC reference
22/PR/1043
Date of REC Opinion
10 Oct 2022
REC opinion
Further Information Favourable Opinion