The Effects of Butyrate Enemas on Visceral Perception

NCT ID: NCT00726817

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Visceral (Hyper)Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

enemas, once daily, containing saline

Group Type PLACEBO_COMPARATOR

Butyrate

Intervention Type DRUG

2

enemas, once daily, containing 50mM butyrate

Group Type EXPERIMENTAL

Butyrate

Intervention Type DRUG

3

enemas, once daily, containing 100mM butyrate

Group Type EXPERIMENTAL

Butyrate

Intervention Type DRUG

Interventions

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Butyrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University

Principal Investigators

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Robert-Jan Brummer, Prof

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC 06-3-020

Identifier Type: -

Identifier Source: org_study_id

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