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Tests treatment safety and results for Cystic Fibrosis (CF)
Official title Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
ClinicalTrials.gov ID: NCT07569419
What this study is testing
What is Linaclotide 290 micrograms?
Linaclotide 290 micrograms is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cystic fibrosis (cf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Linaclotide is a medicine used to treat constipation and irritable bowel syndrome with constipation (IBS-C). It works by acting on the surface of the gut lining, where it increases the movement of salt and water into the bowel.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Aged between 18-60 years.
- Ability to conform to the study protocol, including overnight fasting, dietary and lifestyle restriction, administering linaclotide and placebo...
You likely can't join if
- Contraindication to MRI scanning (i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury, unable...
- 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...
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.