The Effects of Butyrate Enemas on Visceral Perception

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00726817
First received: July 29, 2008
Last updated: July 31, 2008
Last verified: July 2008
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Butyrate Enemas on Visceral Perception

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726817

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

No publications provided

Responsible Party: Robert-Jan Brummer, Prof, Maastricht University
ClinicalTrials.gov Identifier: NCT00726817     History of Changes
Other Study ID Numbers: MEC 06-3-020
Study First Received: July 29, 2008
Last Updated: July 31, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on August 01, 2014