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Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
Sponsor: University of Nottingham
Summary
Linaclotide is a medicine used to treat constipation and irritable bowel syndrome with constipation (IBS-C). It works by acting on the surface of the gut lining, where it increases the movement of salt and water into the bowel. This softens stools, makes them easier to pass, and can also reduce gut pain One advantage of linaclotide is that, unlike some natural substances in the gut, it is stable and can act throughout the intestine. Studies in animals show that it has the strongest effect in the upper small intestine, but it may act in other parts of the bowel as well. In people, however, it is not yet clear whether linaclotide mainly works in the small intestine or in the large intestine (colon). Knowing this is important, because it could help the investigators understand whether linaclotide might also be useful in other conditions, such as cystic fibrosis, where the gut does not handle fluid properly. Linaclotide is taken as a capsule, but less than 1% is absorbed into the bloodstream. Instead, it stays in the gut, where it is broken down into smaller active parts. This means both the small intestine and colon may be exposed to its effects. Until now, it has been hard to study this because traditional methods only measure one part of the gut at a time. A team at the University of Nottingham has developed MRI scanning methods that can safely and non-invasively measure water content in the small intestine and colon. The aim of this pilot study is to use MRI in healthy volunteers to see exactly where linaclotide acts. This knowledge will help optimise future studies in conditions such as cystic fibrosis.
Official title: A Randomised, Placebo-controlled Crossover Study Defining the Mode of Action of Linaclotide in Healthy Volunteers Using MRI
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-03-09
Completion Date
2026-10
Last Updated
2026-05-06
Healthy Volunteers
Yes
Conditions
Interventions
Linaclotide 290 micrograms
290 mcg, 2 days dosing, oral capsule form
Lactose placebo pill
Placebo form, oral capsules identical to linaclotide
Locations (1)
Sir Peter Mansfield Imaging Centre
Nottingham, United Kingdom