Cystic Fibrosis (CF)FEMPTONCT07780344
MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)
A study testing Linaclotide 290 micrograms in people with Cystic Fibrosis (CF), run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Cystic fibrosis (CF) is an inherited condition that affects several organs, including the gut. People with CF often experience uncomfortable digestive symptoms such as bloating, gas, abdominal pain, and constipation. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Linaclotide 290 micrograms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Sir Peter Mansfield Imaging Centre
Nottingham, Gloucestershire, NG7 2UH
Abi Spicer, PhD, +447855 193162, MS-fempto@nottingham.ac.uk
Robin Spiller, MD, +44-7824328319, robin.spiller@nottingham.ac.uk
About this study
Official title: A Feasibility Study Evaluating MRI Parameters as Biomarkers of the Effect of a Secretagogue in Cystic Fibrosis (FEMPTO)
Cystic fibrosis (CF) is an inherited condition that affects several organs, including the gut. People with CF often experience uncomfortable digestive symptoms such as bloating, gas, abdominal pain, and constipation. The root cause is that the gut produces thicker-than-normal mucus, which slows things down and makes it harder for the bowel to work properly.
Current treatments such as laxatives, enemas, or surgery can be inconvenient and don't always work well. There is a real need for better options, and for a clearer understanding of how the CF gut behaves and responds to treatment.
Read more
This study will use MRI, a non-invasive imaging technique, to look at how fluid moves through the gut in adults with CF and the impact of linaclotide. Linaclotide is a licensed medication used to treat chronic constipation and irritable bowel syndrome. It works by encouraging the gut to release more fluid, helping things move more easily. It acts locally in the gut and is not absorbed into the bloodstream. Early research suggests it may help in CF in a way that does not rely on correcting the underlying genetic fault, making it a promising avenue to explore.
Participants will include people with different bowel habits, including those who tend towards constipation and those who tend towards diarrhoea. The scans will help researchers check whether certain MRI measurements can reliably detect changes in gut fluid and movement.
This is a feasibility study; its main objective is to test whether these MRI measurements are useful and practical, and support a sample size calculation, in future CF studies investigating linaclotide effects.
Read the detailed description
Background: The recent James Lind Alliance priority setting listed "How can we relieve gastro-intestinal symptoms, such as stomach pain, bloating and nausea?" as number 3 priority despite treatment with CFTR modulators. The investigators have shown using magnetic resonance imaging (MRI) that pwCF have abnormal small bowel contents which empty more slowly into the colon. This is most likely due to impaired pancreatic, biliary and intestinal secretions leading to hyperviscosity of contents. Linaclotide is a drug which stimulates bicarbonate secretion in the small intestine which has been shown to accelerate transit in mice models of CF but not in patients. Its action would be predicted to reduce mucus viscosity and normalise small bowel contents and transit.
Aims: to perform a mechanistic pilot study using MRI to show that linaclotide normalises small bowel contents and transit times.
Methods: A randomised, placebo-controlled trial of linaclotide in pwCF. Linaclotide 290ug will be taken on the day before and on the MRI study day. Patients will then undergo serial MRI scanning for 6 hours following dosing at time T 0 , with a standard rice pudding meal at time T60 and a second 700kcal meal at T 300 minutes with the final scan at time T360minutes as the investigators have done previously. The investigators will measure small bowel water content (SBWC) as well as time for chyme to enter the colon (orocaecal transit time [OCTT]) and T1 ascending colon(T1AC), a measure of colonic water content. Primary endpoint: SBWC AUC 0-6hours . Secondary endpoints: change in SBWC after second meal from T300 to T360 ( ∆ SBWC), OCTT, T1 AC AUC 0-6 hours, bowel frequency and stool consistency on study day and the following 3 days.
Impact: If successful this will provide a mechanistic rationale for a full 12 week clinical study of linaclotide as adjunctive treatment for pwCF.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- Linaclotide 290 micrograms, Placebo
- Keywords
- MRI, cystic fibrosis, linaclotide
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linaclotide 290 microgramsDrug
linaclotide
PlaceboDrug
lactose 20mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | encapsulated lactose Receives: Drug: Placebo |
| linaclotide | Active comparator | linaclotide 290 ug over-encapsulated identical appearance to placebo Receives: Drug: Linaclotide 290 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small Bowel Water Content AUC 0-6hours
Area under curve Small Bowel Water Content
Measured: from enrolment until study end at approximately 4 weeks
Secondary outcomes (3)
Change in Small Bowel Water Content (SBWC)
change in SBWC after second meal from T300 to T360 ( ∆ SBWC),
Measured: from enrolment until study end at approximately 4 weeks
Orocaecal transit time (OCTT)
Time from meal ingestion to appearance of head of meal in caecum
Measured: from enrolment until study end at approximately 4 weeks
T1 ascending colon
T1 ascending colon(T1AC), a measure of colonic water content.
Measured: from enrolment until study end at approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780344
- Sponsor's protocol ID
- FMHS 185-0526
- Acronym
- FEMPTO
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified information may be shared on request