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The Effects of Butyrate Enemas on Visceral Perception

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726817
First Posted: August 1, 2008
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maastricht University Medical Center
  Purpose
During this double blind, placebo controlled, randomised cross over study, healthy volunteers received an enema once daily for one week containing either placebo (saline), 50mM butyrate or 100mM of butyrate. Before and directly after each test period a barostat protocol was performed to measure parameters for visceral perception.

Condition Intervention
Visceral (Hyper)Sensitivity Drug: Butyrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Butyrate Enemas on Visceral Perception

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Enrollment: 11
Study Start Date: December 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
enemas, once daily, containing saline
Drug: Butyrate
Experimental: 2
enemas, once daily, containing 50mM butyrate
Drug: Butyrate
Experimental: 3
enemas, once daily, containing 100mM butyrate
Drug: Butyrate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • age, under 18 or over 65
  • use of pre- or probiotics during study and 3 months previous to study
  • previous bowel complaints
  • gastrointestinal disease or abdominal surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726817


Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Robert-Jan Brummer, Prof Maastricht University Medical Center
  More Information

Responsible Party: Robert-Jan Brummer, Prof, Maastricht University
ClinicalTrials.gov Identifier: NCT00726817     History of Changes
Other Study ID Numbers: MEC 06-3-020
First Submitted: July 29, 2008
First Posted: August 1, 2008
Last Update Posted: February 24, 2017
Last Verified: July 2008

Keywords provided by Maastricht University Medical Center:
butyrate, visceral perception, compliance

Additional relevant MeSH terms:
Butyric Acid
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs