MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Nottingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

Pregnant (current or planned during the study duration) or breastfeeding

Some antidepressants (SSRIs or low-dose tricyclics)

Antihistamines (for allergies)

The contraceptive pill

Trial design

Design model

Crossover

Treatments tested in this trial

  • Linaclotide 290 micrograms

    Drug

    linaclotide

  • Placebo

    Drug

    lactose 20mg

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: linaclotideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

T1 ascending colon

T1 ascending colon(T1AC), a measure of colonic water content.

Time frame
from enrolment until study end at approximately 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Cystic Fibrosis Trust

Collaborator

This trial is not recruiting at the moment. You can still explore other options: