Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids

SCFA Metabolism Clinical Trial

Official title:

Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271802
• Other study ID #: METC 08-2-006
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: October 21, 2014
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: October 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

In this placebo-controlled randomized parallel study the effects of a butyrate enema on plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera, liver and the splanchnic area are investigated

Description:

Patients undergoing upper abdominal surgery are included. During surgery they receive a butyrate enema or placebo enema. Before and after rectal administration, plasma samples are taken from several veins and arteries to analyse SCFA concentrations and fluxes from portal drained viscera, liver and the splanchnic area.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing open liver resection or pancreaticoduodenectomy

Exclusion Criteria:

• known parenchymal liver disease

• presence of ileostomy or colostomy

• patients with inflammatory bowel disease

• antibiotics, prebiotics or probiotics 2 months prior to surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• SCFA Metabolism

Intervention

Dietary Supplement:
• Sodium butyrate
Patients recieved an enema containing butyrate or a placebo during upper abdominal surgery.
• NaCl

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma SCFAs		0, 5, 15, 30 min after administration	No