Colon, IrritableRUFUSNCT06291272
Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI
A study testing Psyllium, Methylcellulose and Inulin in people with Colon, Irritable, run by University of Nottingham at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon, Irritable
- What is being tested?
- Psyllium, Methylcellulose and Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
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- 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 channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill will be recorded in the CRF but will not be an exclusion criteria).
- Participants who are taking antibiotics or probiotics as it might alters gut microbiota.
- Poor understanding of English language.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Disease Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Randomised Placebo Controlled Trial of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI (RUFUS)
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.
Read the detailed description
Aim The aim is to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will reduce colonic gas volumes assessed by MRI 0-6 hours and 24 hours post ingestion as compared to inulin combined with placebo, maltodextrin.
Objective The primary objective is to define the effect of methylcellulose and /or psyllium on colonic gas as assessed by MRI. Previous studies have used large doses to ensure a large effect to avoid a type II error however the doses used are well outside the normal consumption. The investigators wish to compare the effect of the methylcellulose mix on the fermentation of 15 g of inulin.
Secondary Objectives A) Assess the effect of methylcellulose on gastric emptying, oro-cecal transit time (OCTT) by MRI assessment of arrival of "head of meal", regional MRI colonic appearances, including signal intensity at 6 and 24 hours to determine the likely length of effect, C) to asses breath hydrogen production over 24 hour post ingestion including overnight assessments, D) to assess Whole Gut Transit Time (WGTT) using blue muffins test, E) to measure AUC (0-24) for breath methane; F) to measure gas production over 48 hours incubation in vitro model of colon (in collaboration with Quadram Institute); G) to measure metabolite production (short chain fatty acids) using in vitro model of colon(in collaboration with Quadram Institute); H) to analyse microbiota using 16sRNA gene (in collaboration with Quadram Institute); I) to assess the effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.
- Conditions
- Colon, Irritable
- Being tested
- Psyllium, Methylcellulose, Inulin, Maltodextrin
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
15 g psyllium + 15 g inulin
MethylcelluloseDietary supplement
15 g methylcellulose + 15 g inulin
InulinDietary supplement
15 inulin
MaltodextrinDietary supplement
15 maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Experimental | 375 ml containing 15g inulin made up in 375 ml water with 15 g psyllium husk Receives: Dietary Supplement: Psyllium; Dietary Supplement: Inulin |
| Methylcelulose | Experimental | 375 ml containing 15g inulin made up in 375 ml water with 15g modified methylcellulose Receives: Dietary Supplement: Methylcellulose; Dietary Supplement: Inulin |
| Maltodextrin | Placebo comparator | 375 ml containing 15g inulin made up in 375 ml water with maltodextrin powder (placebo) Receives: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
colonic gas volume
AUC 0-6 hours of colonic gas volume
Measured: 0-6 hours
Secondary outcomes (4)
colonic gas volume at 6 hours
MRI assessed colonic gas volume at 6 hours
Measured: 0-6 hours
Breath hydrogen
Area under curve (AUC) from time 0-6 hours of breath hydrogen (ppm.hours)
Measured: 0-6 hours
Oro-cecal transit time
Measured: 0- 6 hours
24 hour breath hydrogen
Area under curve (AUC) from time 0-24 hours of breath hydrogen (ppm.hours)
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon, IrritableStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3 way cross -over
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291272
- Sponsor's protocol ID
- FMHS 328-0723
- Acronym
- RUFUS
- Status last verified
- Aug 2024
- First submitted
- 26 Feb 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dellschaft N, Alhasani A, Reid JESJ, Hoad CL, Gates E, Whymark M, Yakubov G, Marciani L, Warren FJ, Modasia A, Spicer A, Crooks C, Corsetti M, Gowland PA, Spiller R. Clinical Trial: Randomised Placebo-Controlled Trial of Methylcellulose and Psyllium Gels on Inulin-Induced Colonic Gas. Aliment Pharmacol Ther. 2026 Sep 11. doi: 10.1111/apt.70964. Online ahead of print.
PubMed 42728685
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo Controlled Trial of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI (RUFUS)
- ClinicalTrials.gov ID
- NCT06291272
- Acronym / sponsor ID
- RUFUS / FMHS 328-0723
- Conditions
- Colon, Irritable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim The aim is to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will reduce colonic gas volumes assessed by MRI 0-6 hours and 24 hours post ingestion as compared to inulin combined with placebo, maltodextrin.
Objective The primary objective is to define the effect of methylcellulose and /or psyllium on colonic gas as assessed by MRI. Previous studies have used large doses to ensure a large effect to avoid a type II error however the doses used are well outside the normal consumption. The investigators wish to compare the effect of the methylcellulose mix on the fermentation of 15 g of inulin.
Secondary Objectives A) Assess the effect of methylcellulose on gastric emptying, oro-cecal transit time (OCTT) by MRI assessment of arrival of "head of meal", regional MRI colonic appearances, including signal intensity at 6 and 24 hours to determine the likely length of effect, C) to asses breath hydrogen production over 24 hour post ingestion including overnight assessments, D) to assess Whole Gut Transit Time (WGTT) using blue muffins test, E) to measure AUC (0-24) for breath methane; F) to measure gas production over 48 hours incubation in vitro model of colon (in collaboration with Quadram Institute); G) to measure metabolite production (short chain fatty acids) using in vitro model of colon(in collaboration with Quadram Institute); H) to analyse microbiota using 16sRNA gene (in collaboration with Quadram Institute); I) to assess the effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 way cross -over
| Arm | Type | Receives |
|---|---|---|
| Psyllium | Experimental | Dietary Supplement: Psyllium, Dietary Supplement: Inulin375 ml containing 15g inulin made up in 375 ml water with 15 g psyllium husk |
| Methylcelulose | Experimental | Dietary Supplement: Methylcellulose, Dietary Supplement: Inulin375 ml containing 15g inulin made up in 375 ml water with 15g modified methylcellulose |
| Maltodextrin | Placebo comparator | Dietary Supplement: Inulin, Dietary Supplement: Maltodextrin375 ml containing 15g inulin made up in 375 ml water with maltodextrin powder (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- • Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psyllium15 g psyllium + 15 g inulin | Dietary supplement | Psyllium |
| Methylcellulose15 g methylcellulose + 15 g inulin | Dietary supplement | Methylcelulose |
| Inulin15 inulin | Dietary supplement | Maltodextrin, Methylcelulose, Psyllium |
| Maltodextrin15 maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
colonic gas volume
Time frame: 0-6 hours
AUC 0-6 hours of colonic gas volume
4 secondary outcomes
colonic gas volume at 6 hours
Time frame: 0-6 hours
Breath hydrogen
Time frame: 0-6 hours
Oro-cecal transit time
Time frame: 0- 6 hours
24 hour breath hydrogen
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 42728685Dellschaft N, Alhasani A, Reid JESJ, Hoad CL, Gates E, Whymark M, Yakubov G, Marciani L, Warren FJ, Modasia A, Spicer A, Crooks C, Corsetti M, Gowland PA, Spiller R. Clinical Trial: Randomised Placebo-Controlled Trial of Methylcellulose and Psyllium Gels on Inulin-Induced Colonic Gas. Aliment Pharmacol Ther. 2026 Sep 11. doi: 10.1111/apt.70964. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Spiller, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium, Methylcellulose and Inulin in people with Colon, Irritable, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colonic gas volume (time frame: 0-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.