Effect of Butyrogenic Fibers in IBS Patients | NCT00314886

Studies
Effect of Butyrogenic Fibers in IBS Patients

NCT00314886

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jan 19, 2011Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Diet

Countries

France

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Jul 2005Estimated

First Submitted Date

Apr 13, 2006

First Submission Date that Met QC Criteria

Apr 14, 2006

First Posted Date

Apr 17, 2006Estimated

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

Jan 18, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Collaborators

Name	Class
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement	OTHER
EA 3848 UdA	UNKNOWN
ERT: Clinical Trial Technology Solutions	OTHER

Description Module

Brief Summary

Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.

Detailed Description

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

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
Diet	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discomfort threshold to rectal distension

Secondary Outcomes

Measure	Description	Time Frame
Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
Intestinal discomfort (questionnaire)
Quality of life (questionnaire)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female aged 18-60 years
Normal volunteers and patients with IBS assessed by Rome II criteria
Effective contraception
Affiliated to National Health Service
Having received oral and written information about the study
Having provided her written informed consent

Exclusion Criteria:

Significant clinical or biological abnormality
Organic gastrointestinal disease
Subjects having lower than 15g/day or higher than 20g/day fibres intake
Antibiotic treatment during the month preceding the pre inclusion day
Antispasmodics, antidiarrheics, laxatives, and prokinetics during the week preceding the pre inclusion day and during all the study period.
Digestive surgery tract except appendectomy and cholecystectomy
Alcohol abuse
Drug addiction
Major psychiatric disorder

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michel Dapoigny, Pr	Contact	(33) 04 73 75 05 23

Overall Officials

Name	Affiliation	Role
Michel Dapoigny, Pr	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clermont-Ferrand University Hospital	Recruiting	Clermont-Ferrand	Auvergne	63000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11706290	Background	Dunlop SP, Spiller RC. Nutritional issues in irritable bowel syndrome. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):537-40. doi: 10.1097/00075197-200111000-00013.
7912305	Background	Francis CY, Whorwell PJ. Bran and irritable bowel syndrome: time for reappraisal. Lancet. 1994 Jul 2;344(8914):39-40. doi: 10.1016/s0140-6736(94)91055-3.

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena