MRI scans reveal gut Drug's secrets in healthy volunteers
NCT ID NCT07569419
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how linaclotide, a drug for constipation, affects fluid in the gut. Researchers will use MRI scans to see where the drug works in the small and large intestines. The goal is to learn more about its effects, which could help design future studies for conditions like cystic fibrosis. Healthy volunteers aged 18-60 will take the drug or a placebo and have MRI scans.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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 Not currently taking any medications (except for selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill). 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 rice pudding/blue dye meal, and rating stool frequency and appearance. Exclusion Criteria: Contraindication to MRI scanning (i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury, unable to lie flat and relatively still for less than 5 minutes.) Pregnancy, lactating, or planning pregnancy during the investigation declared by candidate. History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function. Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix). Intestinal stoma. Any medical condition that may potentially compromise participation in the study e.g., known food intolerance to rice pudding, known contraindication to the oral administration of linaclotide or placebo. Has a body mass index (BMI) value less than 18.5 or greater than 35. Will not agree to follow dietary and lifestyle restrictions required. Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study. Participants who are currently (or in the past 3 months) taking antibiotics or probiotics as these may impact GI function. Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM. Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g., cognitive dysfunction, chaotic lifestyle related to substance abuse. Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sir Peter Mansfield Imaging Centre
RECRUITINGNottingham, NG7 2QX, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Glucose sensor may flag diabetes risk in cystic fibrosis
- Can Drug-Level testing personalize cystic fibrosis treatment?
- MRI could reveal a new way to ease gut troubles in cystic fibrosis
- AI may predict lung decline in cystic fibrosis kids using muscle and balance data
- Breathing vs. beating: which technique clears lungs better in cystic fibrosis?
- Could modern CF drugs make daily inhaled treatments obsolete?