NCT02271802

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

October 20, 2014

Last Update Submit

October 21, 2014

Conditions

SCFA Metabolism

Keywords

ButyrateInterorgan metabolismShort-chain fatty acidsGut production

Outcome Measures

Primary Outcomes (1)

  • Plasma SCFAs

    0, 5, 15, 30 min after administration

Study Arms (2)

Butyrate

EXPERIMENTAL

Enema containing sodium butyrate

Dietary Supplement: Sodium butyrate

Placebo

PLACEBO COMPARATOR

Enema containing NaCl

Dietary Supplement: NaCl

Interventions

Sodium butyrateDIETARY_SUPPLEMENT

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

Butyrate
NaClDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing open liver resection or pancreaticoduodenectomy

You may not qualify if:

  • known parenchymal liver disease
  • presence of ileostomy or colostomy
  • patients with inflammatory bowel disease
  • antibiotics, prebiotics or probiotics 2 months prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6229ER, Netherlands

Location

Related Publications (1)

  • van der Beek CM, Bloemen JG, van den Broek MA, Lenaerts K, Venema K, Buurman WA, Dejong CH. Hepatic Uptake of Rectally Administered Butyrate Prevents an Increase in Systemic Butyrate Concentrations in Humans. J Nutr. 2015 Sep;145(9):2019-24. doi: 10.3945/jn.115.211193. Epub 2015 Jul 8.

    PMID: 26156796DERIVED

MeSH Terms

Interventions

Butyric Acid

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • CHC Dejong, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations

NL(1)