Irritable Bowel SyndromeREALISTICNCT06551948
Effect of MethylceIlulose or Psyllium on Fermentation of Inulin Assessed Using a Gas Sensing Capsule
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
The investigators plan to measure the local (in vivo) production of hydrogen when methylcellulose is ingested, to see if the investigators can show a shift of the site of fermentation to the distal colon. 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
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2024to 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.
- Contraindications to Atmo capsule including swallowing disorders, suspected or known strictures or GI surgery within last 3 months or consuming Proton Pump Inhibitors (full details see Atmo manual)
- For any reason, unable to wear or maintain close proximity to (no greater than 1.5 m) the personal receiver which logs the data measured from the Atmo pill for the duration of its whole gut transit.
- Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).
- Intestinal stoma.
Show all 15Show fewer
- 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 MethylceILulose or PSyllium on FermentaTion of Inulin Assessed Using a Gas Sensing Capsule (REALISTIC)
The investigators plan to measure the local (in vivo) production of hydrogen when methylcellulose is ingested, to see if the investigators can show a shift of the site of fermentation to the distal colon.
The investigators will achieve this using the Atmo pill, a recently developed ingestible gas-sensing wireless capsule manufactured by Atmo Biosciences. The pill is very similar in appearance and dimensions (26·8 mm long by 11·7 mm in diameter) to the Smart Pill, an FDA approved wireless capsule which measures local pH, which has been widely and safely used for over a decade. The Smart Pill is recommended for transit measurement by the American ACG Clinical Guidelines on Gastroparesis 3. The Atmo pill differs from the Smart Pill in measuring hydrogen and carbon dioxide within the colonic lumen rather than pH. The pill emits a radio signal to a small device worn by the participant to record the measurements periodically 4.
Read the detailed description
Aim
This pilot study aims to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will delay colonic fermentation compared to inulin combined with placebo (maltodextrin), resulting in an increase in colonic hydrogen concentration in the distal colon as measured by the Atmo pill.
Objective
The primary objective of this pilot is to quantify in vivo the hydrogen gas produced from colonic fermentation post ingestion. Previous studies have measured hydrogen concentration from breath analysis to infer colonic fermentation progression, however the Atmo pill will allow for direct measurement throughout colonic transit. By dividing the mean colonic hydrogen gas production into time quartiles, the investigators can better associate which region of the colon the fermentation is taking place (i.e., 4th quartile to represent distal colon region).
Secondary Objectives
Mean colonic hydrogen% in each quarter of colonic transit.
Mean colonic carbon dioxide% in each quarter of colonic transit.
Colon transit time (CTT) determined from Atmo pill.
Small bowel transit time (SBTT) of Atmo pill to caecum.
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 over 48 hours incubation in vitro model of colon using participants stool samples (in collaboration with Quadram Institute).
Metabolite production (short chain fatty acids) using same in vitro model of colon (in collaboration with Quadram Institute).
Analysis of microbiota in participants stool using 16sRNA gene (in collaboration with Quadram Institute).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- psyllium, methylcellulose, maltodextrin, inulin
- 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
methylcelluloseDietary supplement
15 gm methylcellulose
maltodextrinDietary supplement
15 g maltodextrin
inulinDietary supplement
15g inulin
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Experimental | 15 g psyllium Receives: Dietary Supplement: psyllium; Dietary Supplement: inulin |
| methylcellulose | Experimental | 15 g methylcellulose Receives: Dietary Supplement: methylcellulose; Dietary Supplement: inulin |
| Maltodextrin | Placebo comparator | 15 g maltodextrin Receives: Dietary Supplement: maltodextrin; Dietary Supplement: inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic hydrogen per quarter of colonic transit
mean hydrogen as % of colonic gas during the 4 quarters of colonic transit
Measured: up to 4 days
Secondary outcomes (1)
carbon dioxide gas production
carbon dioxide as % of colonic gas from colonic fermentation post-ingestion of fibre gel drink ll over each quartile of colonic transit (AUC Q1, Q2, Q3, Q4)
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2024
- 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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Principal investigator, Robin Spiller, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551948
- Sponsor's protocol ID
- FMHS 64-1123
- Acronym
- REALISTIC
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandomisEd PlAcebo ControlLed TrIal of MethylceILulose or PSyllium on FermentaTion of Inulin Assessed Using a Gas Sensing Capsule (REALISTIC)
- ClinicalTrials.gov ID
- NCT06551948
- Acronym / sponsor ID
- REALISTIC / FMHS 64-1123
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Aug 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 investigators plan to measure the local (in vivo) production of hydrogen when methylcellulose is ingested, to see if the investigators can show a shift of the site of fermentation to the distal colon.
The investigators will achieve this using the Atmo pill, a recently developed ingestible gas-sensing wireless capsule manufactured by Atmo Biosciences. The pill is very similar in appearance and dimensions (26·8 mm long by 11·7 mm in diameter) to the Smart Pill, an FDA approved wireless capsule which measures local pH, which has been widely and safely used for over a decade. The Smart Pill is recommended for transit measurement by the American ACG Clinical Guidelines on Gastroparesis 3. The Atmo pill differs from the Smart Pill in measuring hydrogen and carbon dioxide within the colonic lumen rather than pH. The pill emits a radio signal to a small device worn by the participant to record the measurements periodically 4.
Detailed description
Aim
This pilot study aims to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will delay colonic fermentation compared to inulin combined with placebo (maltodextrin), resulting in an increase in colonic hydrogen concentration in the distal colon as measured by the Atmo pill.
Objective
The primary objective of this pilot is to quantify in vivo the hydrogen gas produced from colonic fermentation post ingestion. Previous studies have measured hydrogen concentration from breath analysis to infer colonic fermentation progression, however the Atmo pill will allow for direct measurement throughout colonic transit. By dividing the mean colonic hydrogen gas production into time quartiles, the investigators can better associate which region of the colon the fermentation is taking place (i.e., 4th quartile to represent distal colon region).
Secondary Objectives
Mean colonic hydrogen% in each quarter of colonic transit.
Mean colonic carbon dioxide% in each quarter of colonic transit.
Colon transit time (CTT) determined from Atmo pill.
Small bowel transit time (SBTT) of Atmo pill to caecum.
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 over 48 hours incubation in vitro model of colon using participants stool samples (in collaboration with Quadram Institute).
Metabolite production (short chain fatty acids) using same in vitro model of colon (in collaboration with Quadram Institute).
Analysis of microbiota in participants stool using 16sRNA gene (in collaboration with Quadram Institute).
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: inulin15 g psyllium |
| methylcellulose | Experimental | Dietary Supplement: methylcellulose, Dietary Supplement: inulin15 g methylcellulose |
| Maltodextrin | Placebo comparator | Dietary Supplement: maltodextrin, Dietary Supplement: inulin15 g maltodextrin |
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.
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
- Contraindications to Atmo capsule including swallowing disorders, suspected or known strictures or GI surgery within last 3 months or consuming Proton Pump Inhibitors (full details see Atmo manual)
- For any reason, unable to wear or maintain close proximity to (no greater than 1.5 m) the personal receiver which logs the data measured from the Atmo pill for the duration of its whole gut transit.
- Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).
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 | Dietary supplement | Psyllium |
| methylcellulose15 gm methylcellulose | Dietary supplement | methylcellulose |
| maltodextrin15 g maltodextrin | Dietary supplement | Maltodextrin |
| inulin15g inulin | Dietary supplement | Maltodextrin, Psyllium, methylcellulose |
Primary outcome
Colonic hydrogen per quarter of colonic transit
Time frame: up to 4 days
mean hydrogen as % of colonic gas during the 4 quarters of colonic transit
1 secondary outcome
carbon dioxide gas production
Time frame: up to 4 days
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 1 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 1 Apr 2025. 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 hydrogen per quarter of colonic transit (time frame: up to 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.