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OpenTrials
Completed

NCT Number: NCT02271802

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

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

Completed

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Key information

Conditions

SCFA Metabolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6229ER, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Butyrate

Dietary Supplement

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

NaCl

Dietary Supplement

Primary outcomes

  1. Plasma SCFAs

    Time frame: 0, 5, 15, 30 min after administration

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2014
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.