Mode of Action of Butyrate in the Human Colon

Örebro University, Sweden

Status: Completed

Conditions: Healthy; Irritable Bowel Syndrome (IBS)

Treatments: Other: Sodium butyrate bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT05249023

Bolus

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Irritable Bowel Syndrome (IBS) participants

Experimental group

Description:

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

Treatment:

Other: Sodium butyrate bolus

Healthy participants

Experimental group

Description:

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

Treatment:

Other: Sodium butyrate bolus