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The Effects of Butyrate Enemas on Visceral Perception

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ClinicalTrials.gov Identifier: NCT00726817
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : February 24, 2017
Information provided by:
Maastricht University Medical Center

Brief Summary:
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 or disease Intervention/treatment
Visceral (Hyper)Sensitivity Drug: Butyrate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Study Start Date : December 2007
Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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

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

Responsible Party: Robert-Jan Brummer, Prof, Maastricht University
ClinicalTrials.gov Identifier: NCT00726817     History of Changes
Other Study ID Numbers: MEC 06-3-020
First Posted: August 1, 2008    Key Record Dates
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