Proof of principle for linaclotide to improve gut symptoms in cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional study gives adults with cystic fibrosis a linaclotide capsule (290 micrograms) and a matched lactose placebo on separate visits under controlled conditions. Participants consume a standardized rice pudding/blue dye meal and undergo MRI scans to track intestinal fluid distribution and transit. Stool frequency and appearance are recorded alongside imaging to link symptoms with physiological effects. The study is conducted at a single centre (Sir Peter Mansfield Imaging Centre, University of Nottingham).

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

Contraindication to MRI scanning (i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury, unable to lie flat and relatively still for less than 5 minutes.)

Pregnancy, lactating, or planning pregnancy during the investigation declared by candidate.

History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.

Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).

Intestinal stoma.

Any medical condition that may potentially compromise participation in the study e.g., known food intolerance to rice pudding, known contraindication to the oral administration of linaclotide or placebo.

Has a body mass index (BMI) value less than 18.5 or greater than 35.

Will not agree to follow dietary and lifestyle restrictions required.

Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study.

Participants who are currently (or in the past 3 months) taking antibiotics or probiotics as these may impact GI function.

Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM.

Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g., cognitive dysfunction, chaotic lifestyle related to substance abuse.

Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

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Where it's running

• Sir Peter Mansfield Imaging Centre
  Nottingham, United Kingdom Recruiting

Study contacts

• Study coordinator: Josh Thorley, PhD
• Email: josh.thorley@nottingham.ac.uk
• Phone: 07342646598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.