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MRI could reveal a new way to ease gut troubles in cystic fibrosis

NCT ID NCT07780344

Knowledge-focused Sponsor: University of Nottingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether MRI scans can reliably measure fluid movement in the gut of adults with cystic fibrosis, and whether the drug linaclotide changes those measurements. Linaclotide, already used for constipation, works by drawing fluid into the gut to help things move along. The trial involves 12 participants with different bowel habits, who will receive both linaclotide and a placebo, with MRI scans tracking gut fluid and transit time. The goal is to see if these MRI markers are practical for future, larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linaclotide
What this could lead to
If MRI measurements prove reliable, this could pave the way for larger trials testing linaclotide as a new treatment for gut symptoms in cystic fibrosis.
What could go wrong
This is a small feasibility study, so results may not be conclusive. MRI measurements might not reliably detect changes, and linaclotide's benefits in CF are still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • Participant is willing and able to give informed consent for participation in the study. * Proven diagnosis of CF. * 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 two study meals and blue muffins, and rating stool frequency and appearance. Exclusion Criteria: * Pregnant (current or planned during the study duration) or breastfeeding * Currently taking regular medicines (i.e., pain relief medication like ibuprofen/paracetamol) apart from cystic fibrosis medicines (i.e., pancreatic enzyme replacement therapy (PERT) medication, CFTR modulators). There are some other medicines it is OK to take such as: * Some antidepressants (SSRIs or low-dose tricyclics) * Antihistamines (for allergies) * The contraceptive pill * Any resections (surgery) of the intestines, not including removal of the appendix * Serious medical conditions including any other digestive disorder unrelated to CF. * Taken a course of intravenous or oral antibiotics in the last 2 weeks (except prophylactic antibiotics such as azithromycin). * Inability to stop opiates * Inability to have MRI scans (this could be due to some metallic implants, pacemaker, history of metallic foreign body in your eye and penetrating eye injury) * Night shift work during the week before study days * BMI under 18.5 or above 35 kg/m2. * Taken part in a CTIMP study in the last 4 weeks involving invasive procedures. * currently has chronic diarrhoea symptoms.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis (CF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sir Peter Mansfield Imaging Centre

    Nottingham, Gloucestershire, NG7 2UH, United Kingdom

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