Irritable Bowel SyndromeNCT00314886
Effect of Butyrogenic Fibers in IBS Patients
A study testing Diet in people with Irritable Bowel Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diet
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Alcohol abuse
- Drug addiction
- Major psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Michel Dapoigny, Pr contact
France1 site, 1 recruiting
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000
Michel Dapoigny, Pr, (33) 04 73 75 05 23
About this study
Official title: Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet
- Keywords
- Diet, Fiber, Irritable Bowel Syndrome, Colonic Flora
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort threshold to rectal distension
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startJan 2005
- Study completionJul 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, EA 3848 UdA, ERT: Clinical Trial Technology Solutions
- Investigators
- Michel Dapoigny, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314886
- Sponsor's protocol ID
- CHU63-0009
- Status last verified
- Jan 2011
- First submitted
- 13 Apr 2006
- Last updated
- 19 Jan 2011
- Results posted
- No
Publications
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.
PubMed 11706290Francis 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.
PubMed 7912305Harmsen 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.
PubMed 12039758Jones 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.
PubMed 1737146Jones 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.
PubMed 6128447King 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.
PubMed 9777836Snook 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.
PubMed 7865643Tarrerias 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.
PubMed 12435462Bourdu 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.
PubMed 15940632
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
- ClinicalTrials.gov ID
- NCT00314886
- Acronym / sponsor ID
- CHU63-0009
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Diet, Fiber, Irritable Bowel Syndrome, Colonic Flora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, EA 3848 UdA, ERT: Clinical Trial Technology Solutions
- Study start
- Jan 2005
- Study completion
- Jul 2005 (estimated)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet | Drug | – |
Primary outcome
Discomfort threshold to rectal distension
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
- Background: PubMed 11706290Dunlop 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.
- Background: PubMed 7912305Francis 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.
- Background: PubMed 12039758Harmsen 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.
- Background: PubMed 1737146Jones 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.
- Background: PubMed 6128447Jones 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.
- Background: PubMed 9777836King 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.
- Background: PubMed 7865643Snook 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.
- Background: PubMed 12435462Tarrerias 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.
- Background: PubMed 15940632Bourdu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Dapoigny, Pr contact
Michel Dapoigny, Pr principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Irritable Bowel Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Dapoigny, Pr ((33) 04 73 75 05 23), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort threshold to rectal distension. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314886, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2011.