Irritable Bowel SyndromeCOCOA3NCT06494137
Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin
A study testing inulin in people with Irritable Bowel Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2024to Mar 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years old.
- 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.
- 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.
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- 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: Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin (COCOA3)
The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
Read the detailed description
- BACKGROUND AND RATIONALE
The challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Previous studies 1 have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigation will exploiting 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 2.
The mode of action of methylcellulose and psyllium on the reduction in gas production from inulin remains unclear. Possible mechanisms include 1) slowing delivery to the colon by their effect in the small bowel, 2) delayed release of inulin from the dietary fibre gel matrix (i.e. a physical effect) in the colon 3) or a direct effect on the colonic bacteria reducing their production of gas (i.e. a microbiological effect).
References
Aim This pilot study will test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
Objective The primary objective of this pilot is to compare the effect of pre-feeding a gel-forming dietary fibre (methylcellulose or psyllium) compared to placebo (water) on the colonic fermentability of Inulin over the six hours immediately post inulin ingestion as assessed from breath hydrogen production.
Secondary Objectives
- Area under curve (AUC) of breath hydrogen and methane for period 0 - 24hr.
- Orocecal transit time (OCTT) from breath analysis.
- Whole gut transit time assessed by blue muffin test.
- Gas production with in vitro model of colon using participants stool samples (Quadram Institute).
- Metabolite production (short chain fatty acids) using same in vitro model of colon (Quadram Institute).
- Analysis of microbiota in participants stool using 16sRNA gene (in collaboration with Quadram Institute).
- Assessment of habitual dietary FODMAP intake on breath hydrogen response to Inulin
- Conditions
- Irritable Bowel Syndrome
- Being tested
- inulin
- Keywords
- inulin, fermentation, colon
- 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.
inulinOther
inulin from chicory root
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Active comparator | 15g psyllium + 15 inulin dissolved in 250 ml water Receives: Other: inulin |
| Methylcelulose | Active comparator | 15g methylcellulose +15 g inulin dissolved in 250 ml water Receives: Other: inulin |
| Maltodextrin | Placebo comparator | 15g maltodextrin +15 g inulin dissolved in 250 ml water Receives: Other: inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath hydrogen AUC
Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake.
Measured: 0-6 hours
Secondary outcomes (2)
Breath hydrogen AUC
Area under curve (AUC) from time 0-24hours (AUC 0-24) of breath hydrogen (ppm.hour) after consumption of inulin intake.
Measured: 0-24h
Whole gut transit
Time for blue colour to appear after ingesting muffin labelled with blue food colouring
Measured: 0-7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
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 Irritable Bowel SyndromeStudies 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
- randomised placebo controlled crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Responsible party
- Principal investigator, Robin Spiller, University of Nottingham
- Investigators
- Robin C Spiller, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494137
- Sponsor's protocol ID
- FMHS 158-0324
- Acronym
- COCOA3
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.
PubMed 34353864
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin (COCOA3)
- ClinicalTrials.gov ID
- NCT06494137
- Acronym / sponsor ID
- COCOA3 / FMHS 158-0324
- Conditions
- Irritable Bowel Syndrome
- Keywords
- inulin, fermentation, colon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Jul 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 aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
Detailed description
- BACKGROUND AND RATIONALE
The challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Previous studies 1 have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigation will exploiting 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 2.
The mode of action of methylcellulose and psyllium on the reduction in gas production from inulin remains unclear. Possible mechanisms include 1) slowing delivery to the colon by their effect in the small bowel, 2) delayed release of inulin from the dietary fibre gel matrix (i.e. a physical effect) in the colon 3) or a direct effect on the colonic bacteria reducing their production of gas (i.e. a microbiological effect).
References
Aim This pilot study will test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
Objective The primary objective of this pilot is to compare the effect of pre-feeding a gel-forming dietary fibre (methylcellulose or psyllium) compared to placebo (water) on the colonic fermentability of Inulin over the six hours immediately post inulin ingestion as assessed from breath hydrogen production.
Secondary Objectives
- Area under curve (AUC) of breath hydrogen and methane for period 0 - 24hr.
- Orocecal transit time (OCTT) from breath analysis.
- Whole gut transit time assessed by blue muffin test.
- Gas production with in vitro model of colon using participants stool samples (Quadram Institute).
- Metabolite production (short chain fatty acids) using same in vitro model of colon (Quadram Institute).
- Analysis of microbiota in participants stool using 16sRNA gene (in collaboration with Quadram Institute).
- Assessment of habitual dietary FODMAP 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
- randomised placebo controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| Psyllium | Active comparator | Other: inulin15g psyllium + 15 inulin dissolved in 250 ml water |
| Methylcelulose | Active comparator | Other: inulin15g methylcellulose +15 g inulin dissolved in 250 ml water |
| Maltodextrin | Placebo comparator | Other: inulin15g maltodextrin +15 g inulin dissolved in 250 ml water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 65 years old.
- 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 (13 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 |
|---|---|---|
| inulininulin from chicory root | Other | Maltodextrin, Methylcelulose, Psyllium |
Primary outcome
Breath hydrogen AUC
Time frame: 0-6 hours
Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake.
2 secondary outcomes
Breath hydrogen AUC
Time frame: 0-24h
Whole gut transit
Time frame: 0-7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Results publication: PubMed 34353864Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.
- Individual participant dataSharing planned: Undecided
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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 C 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 inulin in people with Irritable Bowel Syndrome, 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 30 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin Spiller, MD (07824328319, robin.spiller@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath hydrogen AUC (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 NCT06494137, 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 30 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.