Mode of Action of Butyrate in the Human Colon

NCT ID: NCT05249023

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2021-02-19

Brief 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. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Irritable Bowel Syndrome (IBS) participants

100 mM sodium butyrate solution containing indigo carmine as a dye agent will be administered to subjects in this arm.

Group Type: EXPERIMENTAL

Sodium butyrate bolus

Intervention Type: OTHER

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.

Healthy participants

100 mM sodium butyrate solution containing indigo carmine as a dye agent will be administered to subjects in this arm.

Group Type: EXPERIMENTAL

Sodium butyrate bolus

Intervention Type: OTHER

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.

Interventions

Sodium butyrate bolus

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• signed informed consent
• Fulfilled Rome IV diagnostic criteria for IBS (for IBS participants)

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Robert Brummer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Örebro

Örebro, Örebro County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 40810534 (View on PubMed)

Other Identifiers

Bolus

Identifier Type: -

Identifier Source: org_study_id