An interventional study of Linaclotide 290 micrograms and Placebo in Cystic Fibrosis (CF), sponsored by University of Nottingham. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University of Nottingham · Not applicable, Interventional, and Basic science
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Among 235 studies in Cystic Fibrosis with a site in United Kingdom — 20 open to participants now, 31 under way, 4 of them phase 3. Cystic Fibrosis · United Kingdom.
Among the 235 studies in Cystic Fibrosis with a site in United Kingdom, this one is the 162nd largest by planned enrollment of the 186 interventional ones that give a count, is one of 7 that started in 2026, is one of 39 with no phase, reaches primary completion later than 15 of the 30 other live ones, and was the 233rd registered.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
Browse Cystic Fibrosis studies →20 of the 235 studies in Cystic Fibrosis with a site in United Kingdom are open now. Recruiting first, the newest first:
Aimmune Nestlé Health Science US R&D, LLC · Sites in United Kingdom, United States, Bulgaria and 4 more countries
Ages 18–85
University of Nottingham · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
Alexander Horsley · Sites in United Kingdom
Ages 16+
Papworth Hospital NHS Foundation Trust · Sites in United Kingdom
Ages 18+
Royal Brompton & Harefield NHS Foundation Trust · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 156 Cystic Fibrosis studies recruiting now, 95 (61%) set no upper age limit and 45 (29%) stop at 75 or younger; 86 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
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235 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 53 · Phase 3 62 · Phase 4 9
First in 2001; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 12 is below the median of 36 across 1,053 interventional studies indexed under Cystic Fibrosis.
Median enrollment 69 across the 186 interventional studies, 77 across the 48 observational. Of the 186 that completed or were terminated, 83 (45%) have results posted.
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124 of 235 have an industry lead sponsor. The 10 most frequent:
University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.
University of Nottingham has 5 studies filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Cystic Fibrosis with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06460506Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older | 2027-09-30 |
| NCT06237335ReCode TherapeuticsA Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF | 2026-11 |
| NCT07780344University of NottinghamMRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO) | 2027-05 |
| NCT07879651Royal Brompton & Harefield NHS Foundation TrustSPutum Induction and Nebuliser deviCEs for Patients With CF | 2027-06 |
| NCT07559175Aimmune Nestlé Health Science US R&D, LLCA Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency. | 2027-06 |
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Among the 235 studies in Cystic Fibrosis with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
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Participant is willing and able to give for participation in the study.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
encapsulated lactose
Drug: Placebo
linaclotide 290 ug over-encapsulated identical appearance to placebo
Drug: Linaclotide 290 micrograms
linaclotide
lactose 20mg
Small Bowel Water Content AUC 0-6hours
Area under curve Small Bowel Water Content
Time frame: from enrolment until study end at approximately 4 weeks
Change in Small Bowel Water Content (SBWC)
change in SBWC after second meal from T300 to T360 ( ∆ SBWC),
Time frame: 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
Time frame: from enrolment until study end at approximately 4 weeks
T1 ascending colon
T1 ascending colon(T1AC), a measure of colonic water content.
Time frame: from enrolment until study end at approximately 4 weeks
Plan to share: Yes — De-identified information may be shared on request
Supporting information: Study protocol, Clinical study report
Time frame: May 2027 for 7 years
Access criteria: Access via principle investigator
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
Of 214 non-industry interventional studies with no phase under Cystic Fibrosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 8 months is below that.
Counting every sponsor, half of 229 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Linaclotide