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

Not Applicable

Completed

• Conditions: SCFA Metabolism
• Interventions: Dietary Supplement: Sodium butyrate; Dietary Supplement: NaCl

• Registration Number: NCT02271802
• Lead Sponsor: Maastricht University Medical Center

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-21
• Last Update Submitted: 2014-10-21
• Study First Posted: 2014-10-22
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butyrate	Sodium butyrate	Enema containing sodium butyrate
Placebo	NaCl	Enema containing NaCl

Primary Outcome Measures

Name	Time	Method
Plasma SCFAs	0, 5, 15, 30 min after administration

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands