Irritable Bowel SyndromeCOCOA2NCT05911347
Effect of Modified Cellulose on Colonic Fermentation of Inulin
A study testing Psyllium, Methylcellulose and Maltodextrin in people with Irritable Bowel Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Psyllium, Methylcellulose and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2023to 31 Aug 2023
- 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
- Aged 18 or older.
- 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 sampling period.
Who cannot join
- Pregnancy 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.
- Will not agree to dietary restrictions required.
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- 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
University Hospital Clinical Research Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. The investigators will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.
Read the detailed description
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours.
Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. Whole gut transit time will be assessed from the time that stool turns blue after ingestion of a muffin labelled with blue food colouring.
Secondary endpoint:
- AUC (0-24h) breath hydrogen / methane
- Oro-cecal transit time and whole gut transit time.
- Gas production/ metabolites/ microbiota during in vitro fermentation studies at Quadram
- Effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.
The interventions will be dietary interventions, using all food grade materials (sugars and fibres) provided in commonly used doses:
Breath hydrogen will be correlated with in vitro carbohydrate fermentation profile assessed using stool samples collected before intervention
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Psyllium, Methylcellulose, Maltodextrin
- Keywords
- FODMAP, Inulin, Psyllium, Cellulose
- 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
15g psyllium added to inulin solution to form a gel
MethylcelluloseDietary supplement
15 g methylcellulose added to inulin solution to form a gel
MaltodextrinDietary supplement
15g maltodextrin added to inulin solution to form a gel
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Active comparator | Psyllium 15 g+ inulin 15 gm in 375ml water Receives: Dietary Supplement: Psyllium |
| maltodextrin | Placebo comparator | Maltodextrin 15 g + inulin 15 gm in 375 ml water Receives: Dietary Supplement: Maltodextrin |
| Methylcellulose | Experimental | Methylcellulose 15g + Inulin 15 g in 375 ml water Receives: Dietary Supplement: Methylcellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath hydrogen
AUC 0-6 hours after ingestion
Measured: 0-6 hoursafter ingestion
Secondary outcomes (3)
Breath hydrogen
AUC 0-24 hours
Measured: 0-24 hours post ingestion
Breath methane
AUC 0-24 hours
Measured: 0-24 hours post ingestion
Transit time
whole gut transit time
Measured: Whole gut transit measured once before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start9 May 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 3 way cross-over
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Robin D Spiller, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911347
- Sponsor's protocol ID
- FMHS 19-0622
- Acronym
- COCOA2
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34353864Reid JESJ, Alhasani AT, MacCalman T, Amor D, Aliyu AI, Modasia AA, Harris H, Warren FJ, Hoad C, Gowland PA, Yakubov GE, Crooks C, Corsetti M, Marciani L, Spiller RC. A randomised, placebo-controlled trial in healthy humans of modified cellulose or psyllium evaluating the role of gelation in altering colonic gas production during inulin co-administration. Food Funct. 2026 Feb 23;17(4):1794-1805. doi: 10.1039/d5fo03532e.
PubMed 41636227
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)
- ClinicalTrials.gov ID
- NCT05911347
- Acronym / sponsor ID
- COCOA2 / FMHS 19-0622
- Conditions
- Irritable Bowel Syndrome
- Keywords
- FODMAP, Inulin, Psyllium, Cellulose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 9 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 22 Jun 2023 (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.
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. The investigators will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.
Detailed description
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours.
Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. Whole gut transit time will be assessed from the time that stool turns blue after ingestion of a muffin labelled with blue food colouring.
Secondary endpoint:
- AUC (0-24h) breath hydrogen / methane
- Oro-cecal transit time and whole gut transit time.
- Gas production/ metabolites/ microbiota during in vitro fermentation studies at Quadram
- Effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.
The interventions will be dietary interventions, using all food grade materials (sugars and fibres) provided in commonly used doses:
Breath hydrogen will be correlated with in vitro carbohydrate fermentation profile assessed using stool samples collected before intervention
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 way cross-over
| Arm | Type | Receives |
|---|---|---|
| Psyllium | Active comparator | Dietary Supplement: PsylliumPsyllium 15 g+ inulin 15 gm in 375ml water |
| maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin 15 g + inulin 15 gm in 375 ml water |
| Methylcellulose | Experimental | Dietary Supplement: MethylcelluloseMethylcellulose 15g + Inulin 15 g in 375 ml water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 or older.
- 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 sampling period.
Key exclusion criteria (12 listed)
- Pregnancy 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.
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 |
|---|---|---|
| Psyllium15g psyllium added to inulin solution to form a gel | Dietary supplement | Psyllium |
| Methylcellulose15 g methylcellulose added to inulin solution to form a gel | Dietary supplement | Methylcellulose |
| Maltodextrin15g maltodextrin added to inulin solution to form a gel | Dietary supplement | maltodextrin |
Primary outcome
Breath hydrogen
Time frame: 0-6 hoursafter ingestion
AUC 0-6 hours after ingestion
3 secondary outcomes
Breath hydrogen
Time frame: 0-24 hours post ingestion
Breath methane
Time frame: 0-24 hours post ingestion
Transit time
Time frame: Whole gut transit measured once before intervention
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 15 Aug 2024.
- Background: 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.
- Derived from this study: PubMed 41636227Reid JESJ, Alhasani AT, MacCalman T, Amor D, Aliyu AI, Modasia AA, Harris H, Warren FJ, Hoad C, Gowland PA, Yakubov GE, Crooks C, Corsetti M, Marciani L, Spiller RC. A randomised, placebo-controlled trial in healthy humans of modified cellulose or psyllium evaluating the role of gelation in altering colonic gas production during inulin co-administration. Food Funct. 2026 Feb 23;17(4):1794-1805. doi: 10.1039/d5fo03532e.
- 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 D Spiller, MD principal investigator
University of Nottingham
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 Maltodextrin 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 12 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 15 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?
Breath hydrogen (time frame: 0-6 hoursafter ingestion). 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 NCT05911347, which also lists 2 linked publications.
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 15 Aug 2024.