CompletedNot Applicable

Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI

United Kingdom22 participantsStarted 2023-10-15

Plain-language summary

The challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of fermentable oligo-di- and mono-saccharides and polyhydric alcohols (FODMAPs). Studies will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). The investigators are currently performing the COCOA2 study (Effect of modified cellulose on colonic fermentation of inulin) using a modified methylcellulose (results awaited). The investigators now wish to image what happens in the colon when methylcellulose is ingested to enable planning of the next step in the research programme.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to give informed consent. * Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale (5). * Agrees to consume the meals provided. * Agrees to not smoke during the breath hydrogen sampling period. Exclusion Criteria: * • Pregnancy, lactating, or planning pregnancy during the course of 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. * Have contraindications for 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. * Any medical condition making participation potentially compromising participation in the study e.g., diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances. * 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 channe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

colonic gas volume

Timeframe: 0-6 hours

Trial details

NCT IDNCT06291272

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Colon, Irritable trials