The Effects of Butyrate Enemas on Visceral Perception | NCT00726817

Studies
The Effects of Butyrate Enemas on Visceral Perception

NCT00726817

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 24, 2017Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Visceral (Hyper)Sensitivity

Interventions

Butyrate

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Not provided

First Submitted Date

Jul 29, 2008

First Submission Date that Met QC Criteria

Jul 31, 2008

First Posted Date

Aug 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2017

Last Update Posted Date

Feb 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Butyrate	Drug		1 2 3

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert-Jan Brummer, Prof	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht	Limburg	6200MD	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002087	Butyrates

Ancestor Terms

ID	Term
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005232	Fatty Acids, Volatile

Browse Leaves

Not provided

Browse Branches

Not provided