- Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis — Recruiting • EARLY_PHASE1 • Respiratory / COPD / Asthma • NCT07569419.
- What is being tested: Linaclotide, a guanylate cyclase-C agonist currently licensed for constipation and IBS-C, is being evaluated as a potential treatment for cystic fibrosis by increasing salt and water secretion into the bowel to improve stool consistency and clearance.
- Patient eligibility overview: The trial recruits patients with cystic fibrosis who experience constipation and intestinal complications; specific age, lung function, and pancreatic status criteria determine individual eligibility for participation.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : Participant is willing and able to give informed consent for participation in the study Not currently taking any medications (except for selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill). Aged between 18-60 years. Ability to conform to the study protocol, including overnight fasting, dietary and lifestyle restriction, administering linaclotide and placebo intervention, MRI scanning, consuming the rice pudding/blue dye meal, and rating stool frequency and appearance.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.