Back to resultsEffect of Butyrogenic Fibers in IBS Patients
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Diet, Fiber, Irritable Bowel Syndrome, Colonic Flora
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
Sites / Locations
- Clermont-Ferrand University HospitalRecruiting
Outcomes
Primary Outcome Measures
Discomfort threshold to rectal distension
Secondary Outcome Measures
Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
Intestinal discomfort (questionnaire)
Quality of life (questionnaire)
Taxonomic composition of colonic flora
Functional composition of colonic flora
Fermentation profile of ingested fibre
Full Information
NCT ID
NCT00314886
First Posted
April 13, 2006
Last Updated
January 18, 2011
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, EA 3848 UdA, ERT: Clinical Trial Technology Solutions
1. Study Identification
Unique Protocol Identification Number
NCT00314886
Brief Title
Effect of Butyrogenic Fibers in IBS Patients
Official Title
Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, EA 3848 UdA, ERT: Clinical Trial Technology Solutions
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Diet, Fiber, Irritable Bowel Syndrome, Colonic Flora
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diet
Primary Outcome Measure Information:
Title
Discomfort threshold to rectal distension
Secondary Outcome Measure Information:
Title
Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
Title
Intestinal discomfort (questionnaire)
Title
Quality of life (questionnaire)
Title
Taxonomic composition of colonic flora
Title
Functional composition of colonic flora
Title
Fermentation profile of ingested fibre
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Dapoigny, Pr
Phone
(33) 04 73 75 05 23
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Dapoigny, Pr
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Dapoigny, Pr
Phone
(33) 04 73 75 05 23
12. IPD Sharing Statement
Citations:
PubMed Identifier
11706290
Citation
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.
Results Reference
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PubMed Identifier
7912305
Citation
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.
Results Reference
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PubMed Identifier
12039758
Citation
Harmsen HJ, Raangs GC, He T, Degener JE, Welling GW. Extensive set of 16S rRNA-based probes for detection of bacteria in human feces. Appl Environ Microbiol. 2002 Jun;68(6):2982-90. doi: 10.1128/AEM.68.6.2982-2990.2002.
Results Reference
background
PubMed Identifier
1737146
Citation
Jones R, Lydeard S. Irritable bowel syndrome in the general population. BMJ. 1992 Jan 11;304(6819):87-90. doi: 10.1136/bmj.304.6819.87.
Results Reference
background
PubMed Identifier
6128447
Citation
Jones VA, McLaughlan P, Shorthouse M, Workman E, Hunter JO. Food intolerance: a major factor in the pathogenesis of irritable bowel syndrome. Lancet. 1982 Nov 20;2(8308):1115-7. doi: 10.1016/s0140-6736(82)92782-9.
Results Reference
background
PubMed Identifier
9777836
Citation
King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9. doi: 10.1016/s0140-6736(98)02146-1.
Results Reference
background
PubMed Identifier
7865643
Citation
Snook J, Shepherd HA. Bran supplementation in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 1994 Oct;8(5):511-4. doi: 10.1111/j.1365-2036.1994.tb00323.x.
Results Reference
background
PubMed Identifier
12435462
Citation
Tarrerias AL, Millecamps M, Alloui A, Beaughard C, Kemeny JL, Bourdu S, Bommelaer G, Eschalier A, Dapoigny M, Ardid D. Short-chain fatty acid enemas fail to decrease colonic hypersensitivity and inflammation in TNBS-induced colonic inflammation in rats. Pain. 2002 Nov;100(1-2):91-7. doi: 10.1016/s0304-3959(02)00234-8.
Results Reference
background
PubMed Identifier
15940632
Citation
Bourdu S, Dapoigny M, Chapuy E, Artigue F, Vasson MP, Dechelotte P, Bommelaer G, Eschalier A, Ardid D. Rectal instillation of butyrate provides a novel clinically relevant model of noninflammatory colonic hypersensitivity in rats. Gastroenterology. 2005 Jun;128(7):1996-2008. doi: 10.1053/j.gastro.2005.03.082.
Results Reference
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Effect of Butyrogenic Fibers in IBS Patients
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