MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)

NCT07780344 | Not Yet Recruiting

• 1 other identifier: FMHS 185-0526
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cystic Fibrosis (CF)

Keywords

MRI; cystic fibrosis; linaclotide

Outcome Measures

Primary Outcomes (1)

• Small Bowel Water Content AUC 0-6hours

  Area under curve Small Bowel Water Content

  from enrolment until study end at approximately 4 weeks

Secondary Outcomes (3)

• Change in Small Bowel Water Content (SBWC)

  from enrolment until study end at approximately 4 weeks

• Orocaecal transit time (OCTT)

  from enrolment until study end at approximately 4 weeks

• T1 ascending colon

  from enrolment until study end at approximately 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

encapsulated lactose

Drug: Placebo

linaclotide

ACTIVE COMPARATOR

linaclotide 290 ug over-encapsulated identical appearance to placebo

Drug: Linaclotide 290 micrograms

Interventions

Linaclotide 290 micrograms DRUG

linaclotide

linaclotide

Placebo DRUG

lactose 20mg

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cystic Fibrosis Trust: collaborator
• University of Nottingham: lead

Study Sites (1)

Sir Peter Mansfield Imaging Centre

Nottingham, Gloucestershire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Abi Spicer, PhD

CONTACT

+44-7855 193162; MS-fempto@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: drug over encapsulated with matching placebo
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised, placebo-controlled trial

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: May 2027 for 7 years
• Access Criteria: Access via principle investigator

Locations

GB (1)