NCT00726817

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
Last Updated

February 24, 2017

Status Verified

July 1, 2008

Enrollment Period

2 months

First QC Date

July 29, 2008

Last Update Submit

February 22, 2017

Conditions

Visceral (Hyper)Sensitivity

Keywords

butyrate, visceral perception, compliance

Study Arms (3)

1

PLACEBO COMPARATOR

enemas, once daily, containing saline

Drug: Butyrate

2

EXPERIMENTAL

enemas, once daily, containing 50mM butyrate

Drug: Butyrate

3

EXPERIMENTAL

enemas, once daily, containing 100mM butyrate

Drug: Butyrate

Interventions

ButyrateDRUG
123

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200MD, Netherlands

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Acids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Robert-Jan Brummer, Prof

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Last Updated

February 24, 2017

Record last verified: 2008-07

Locations

NL(1)