Effects of Butyrate on Colonic Health of Patients With Di... | NCT00696098

Studies
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission

NCT00696098

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 24, 2017Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Gut Health

Interventions

sodium butyrate
NaCl

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

Oct 2009

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

May 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 9, 2008

First Submission Date that Met QC Criteria

Jun 9, 2008

First Posted Date

Jun 12, 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

Name	Class
Top Institute Food and Nutrition	OTHER

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

Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres. Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in the regulation of epithelial cell proliferation and differentiation, immune function and mucosal protection.

Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate, which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate enemas have been proven to be effective in the treatment of active ulcerative colitis.

In the present study, the direct effects of butyrate on inflammation and parameters of colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade inflammation in the large intestine, and can therefore be used as a model to study the mechanistic effects of butyrate. The design used to study the effects of butyrate in both patient groups will be a double blind randomized placebo-controlled parallel design.

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	sodium butyrate	Other: sodium butyrate
2	Placebo Comparator		Other: NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium butyrate	Other	1 enema (60 ml) once daily containing 100mM	1

Measure	Description	Time Frame
inflammatory parameters		okt 2008

Measure	Description	Time Frame
oxidative stress parameters		okt 2008

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of UC or Diarrhea predominant IBS
Stable western diet
Age between 18 and 65
BMI between 18 and 35
Written informed consent

Exclusion Criteria:

All enemas and suppository during or 2 weeks prior to the study
Use of corticosteroids during or 1 month prior to the study
Use of antibiotics during or 3 months prior to the study
Budesonide during or 2 weeks prior to the study
Changes in medication during or 1 month prior to the study
Lactation, pregnancy and planning of pregnancy
Previous intestinal surgery
Clinically significant systemic diseases
Excessive drinking (>20 alcoholic consumptions per week)
Changes in prebiotic and/or probiotic use during and 2 weeks prior to the study
Previous radiotherapy or chemotherapy

Accepts Healthy Volunteers

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
Fred Troost, PhD	Maastricht University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maastricht		Maastricht	Limburg	6202 MD	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
D020148	Butyric Acid

Ancestor Terms

ID	Term
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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