Irritable Bowel Syndrome (IBS)NCT05249023
Mode of Action of Butyrate in the Human Colon
A study testing Sodium butyrate bolus in people with Irritable Bowel Syndrome (IBS) and Healthy, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Butyrate has recently gained attention as an important microbial compound in human colon health. Several diseases, including Irritable Bowel Syndrome (IBS), have been linked with a loss of butyrate in the colon resulting in the hypothesis that butyrate is important for disease resistance. 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 (IBS), Healthy
- What is being tested?
- Sodium butyrate bolus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSweden
- Study dates
- 11 Apr 2018to 19 Feb 2021
- 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
- signed informed consent
- Fulfilled Rome IV diagnostic criteria for IBS (for IBS participants)
Who cannot join
- known gastrointestinal diseases
- previous complicated gastrointestinal surgery (including e.g. appendectomy or cholecystectomy)
- pregnancy or breast-feeding
- use of antibiotics within the last 12 weeks before the colonoscopy procedure
- regular consumption of probiotics within the last 4 weeks before the colonoscopy procedure
- use of laxatives or anti-diarrhoeals within the last 4 weeks before the colonoscopy procedure
Show all 10Show fewer
- use of serotonin selective re-uptake inhibitors (SSRI) or serotonin nor-epinephrine re-uptake inhibitors (SNRI) with the last 12 weeks before the colonoscopy procedure
- alcohol or drug abuse
- latex allergy
- any other clinically significant disease/condition which in the investigator's opinion could interfere with the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Butyrate has recently gained attention as an important microbial compound in human colon health. Several diseases, including Irritable Bowel Syndrome (IBS), have been linked with a loss of butyrate in the colon resulting in the hypothesis that butyrate is important for disease resistance. However, despite a plethora of preclinical evidence about butyrate's role in colon health, data from human studies are insufficient, largely due to the lack of available tools for colon-specific butyrate delivery and sampling. This project will elucidate butyrate's mode of action in the human colon and its implications for gut functioning in IBS and healthy participants by employing a unique in vivo human setting. Specifically, the regulatory capacity of butyrate on intestinal barrier function and the transcriptional host responses that are associated with an increase of butyrate in the colon will be determined. Moreover, butyrate's role as a signalling molecule for gut hormones and serotonin release will be studied.
- Conditions
- Irritable Bowel Syndrome (IBS), Healthy
- Being tested
- Sodium butyrate bolus
- 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.
Sodium butyrate bolusOther
On the test day participants suffering from IBS and healthy participants will undergo a distal colonoscopy procedure for the collection of mucosal biopsy specimens pre- and post-administration of a sodium butyrate solution (100 mM) at a selected area in the descending colon. Biopsies will be obtained from the colon pre- and 90 min post-administration of the intervention solution. Blood samples will be collected before and at six time-points after the intervention solution administration.
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Syndrome (IBS) participants | Experimental | 100 mM sodium butyrate solution containing indigo carmine as a dye agent will be administered to subjects in this arm. Receives: Other: Sodium butyrate bolus |
| Healthy participants | Experimental | 100 mM sodium butyrate solution containing indigo carmine as a dye agent will be administered to subjects in this arm. Receives: Other: Sodium butyrate bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic permeability ex vivo in Ussing chambers
Difference in the translocation of FITC-labeled dextran and horseradish peroxidase between the study arms before and after exposure to the butyrate bolus
Measured: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution
Secondary outcomes (13)
Butyrate uptake ex vivo in Ussing chambers
Difference in the uptake of C14-labelled butyrate between the study arms before and after exposure to the butyrate bolus
Measured: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution
Regulation of gene expression
Difference in the genome-wide transcriptional response to an increase of butyrate in the descending colon between the study arms before and after exposure to the butyrate bolus
Measured: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution
Concentrations of blood glucagon like peptide-1 (GLP-1)
Difference in blood levels of GLP-1 between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood glucagon like peptide-2 (GLP-2)
Difference in blood levels of GLP-2 between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood peptide YY (PYY)
Difference in blood levels of PYY between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood gastric inhibitory polypeptide (GIP)
Difference in blood levels of GIP between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood insulin
Difference in blood levels of insulin between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood glucagon
Difference in blood levels of glucagon between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood leptin
Difference in blood levels of leptin between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood glucose
Difference in blood levels of glucose between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood serotonin
Difference in blood levels of serotonin between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood metabolites in the gluconeogenic pathway
Difference in blood levels of metabolites in the gluconeogenic pathway between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood butyrate
Difference in blood levels of butyrate between the study arms before and after exposure to the butyrate bolus
Measured: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start11 Apr 2018
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
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 Syndrome (IBS)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249023
- Sponsor's protocol ID
- Bolus
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scharf MW, Forsgard RA, Prado SBR, Ganda Mall JP, Repsilber D, Brummer RJ, Marques TM, Wall R. Acute effects of butyrate on intestinal permeability in patients with irritable bowel syndrome assessed by a novel colonoscopy research model. Gut Microbes. 2025 Dec;17(1):2545414. doi: 10.1080/19490976.2025.2545414. Epub 2025 Aug 14.
PubMed 40810534
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mode of Action of Butyrate in the Human Colon
- ClinicalTrials.gov ID
- NCT05249023
- Acronym / sponsor ID
- Bolus
- Conditions
- Irritable Bowel Syndrome (IBS), Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 21 Feb 2022 (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.
Butyrate has recently gained attention as an important microbial compound in human colon health. Several diseases, including Irritable Bowel Syndrome (IBS), have been linked with a loss of butyrate in the colon resulting in the hypothesis that butyrate is important for disease resistance. However, despite a plethora of preclinical evidence about butyrate's role in colon health, data from human studies are insufficient, largely due to the lack of available tools for colon-specific butyrate delivery and sampling. This project will elucidate butyrate's mode of action in the human colon and its implications for gut functioning in IBS and healthy participants by employing a unique in vivo human setting. Specifically, the regulatory capacity of butyrate on intestinal barrier function and the transcriptional host responses that are associated with an increase of butyrate in the colon will be determined. Moreover, butyrate's role as a signalling molecule for gut hormones and serotonin release will be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irritable Bowel Syndrome (IBS) participants | Experimental | Other: Sodium butyrate bolus100 mM sodium butyrate solution containing indigo carmine as a dye agent will be administered to subjects in this arm. |
| Healthy participants | Experimental | Other: Sodium butyrate bolus100 mM sodium butyrate solution containing indigo carmine as a dye agent will be administered to subjects in this arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- signed informed consent
- Fulfilled Rome IV diagnostic criteria for IBS (for IBS participants)
Key exclusion criteria (10 listed)
- known gastrointestinal diseases
- previous complicated gastrointestinal surgery (including e.g. appendectomy or cholecystectomy)
- pregnancy or breast-feeding
- use of antibiotics within the last 12 weeks before the colonoscopy procedure
- regular consumption of probiotics within the last 4 weeks before the colonoscopy procedure
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 |
|---|---|---|
| Sodium butyrate bolusOn the test day participants suffering from IBS and healthy participants will undergo a distal colonoscopy procedure for the collection of mucosal biopsy specimens pre- and post-administration of a sodium butyrate solution (100 mM) at a selected area in the descending colon. Biopsies will be obtained from the colon pre- and 90 min post-administration of the intervention solution. Blood samples will be collected before and at six time-points after the intervention solution administration. | Other | Healthy participants, Irritable Bowel Syndrome (IBS) participants |
Primary outcome
Colonic permeability ex vivo in Ussing chambers
Time frame: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution
Difference in the translocation of FITC-labeled dextran and horseradish peroxidase between the study arms before and after exposure to the butyrate bolus
13 secondary outcomes
Butyrate uptake ex vivo in Ussing chambers
Time frame: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution
Regulation of gene expression
Time frame: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution
Concentrations of blood glucagon like peptide-1 (GLP-1)
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood glucagon like peptide-2 (GLP-2)
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood peptide YY (PYY)
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood gastric inhibitory polypeptide (GIP)
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood insulin
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood glucagon
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood leptin
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood glucose
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood serotonin
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood metabolites in the gluconeogenic pathway
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
Concentrations of blood butyrate
Time frame: Blood samples collected before (0 min) and at six timepoints after the butyrate solution administration (5, 15, 30, 45, 60 and 90 min).
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 21 Feb 2022.
- Derived from this study: PubMed 40810534Scharf MW, Forsgard RA, Prado SBR, Ganda Mall JP, Repsilber D, Brummer RJ, Marques TM, Wall R. Acute effects of butyrate on intestinal permeability in patients with irritable bowel syndrome assessed by a novel colonoscopy research model. Gut Microbes. 2025 Dec;17(1):2545414. doi: 10.1080/19490976.2025.2545414. Epub 2025 Aug 14.
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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 Sodium butyrate bolus in people with Irritable Bowel Syndrome (IBS) and Healthy, run by Örebro University, Sweden at 1 site in Sweden.
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 2 inclusion and 10 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 21 Feb 2022. 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 Sweden. 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. 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 permeability ex vivo in Ussing chambers (time frame: Mucosal biopsies collected pre- and 90 min post-administration of the butyrate solution). 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 NCT05249023, 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 21 Feb 2022.