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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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SCFA Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Butyrate

Enema containing sodium butyrate

Group Type EXPERIMENTAL

Sodium butyrate

Intervention Type DIETARY_SUPPLEMENT

Patients recieved an enema containing butyrate or a placebo during upper abdominal surgery.

Placebo

Enema containing NaCl

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Sodium butyrate

Patients recieved an enema containing butyrate or a placebo during upper abdominal surgery.

Intervention Type DIETARY_SUPPLEMENT

NaCl

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No