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The Effects of Butyrate Enemas on Visceral Perception

Primary Purpose

Visceral (Hyper)Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Butyrate
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Visceral (Hyper)Sensitivity focused on measuring butyrate, visceral perception, compliance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

enemas, once daily, containing saline

enemas, once daily, containing 50mM butyrate

enemas, once daily, containing 100mM butyrate

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 29, 2008
Last Updated
February 22, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00726817
Brief Title
The Effects of Butyrate Enemas on Visceral Perception
Official Title
The Effects of Butyrate Enemas on Visceral Perception
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral (Hyper)Sensitivity
Keywords
butyrate, visceral perception, compliance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
enemas, once daily, containing saline
Arm Title
2
Arm Type
Experimental
Arm Description
enemas, once daily, containing 50mM butyrate
Arm Title
3
Arm Type
Experimental
Arm Description
enemas, once daily, containing 100mM butyrate
Intervention Type
Drug
Intervention Name(s)
Butyrate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert-Jan Brummer, Prof
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200MD
Country
Netherlands

12. IPD Sharing Statement

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The Effects of Butyrate Enemas on Visceral Perception

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