Irritable Bowel SyndromeNCT00806104
Fructo-oligosaccharides and Irritable Bowel Syndrome
A study testing Fructo-oligosaccharides and Maltodextrins in people with Irritable Bowel Syndrome, run by Beghin-Meiji at 2 sites in 2 countries.
Trial summary
Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fructo-oligosaccharides and Maltodextrins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to Dec 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- IBS subjects according to Rome III criteria
- Incomfort below or equivalent to 30mmHg during Tensostat test
- between 18 and 60 years
- no antibiotic treatment for the last 2 months
- less than 20g of dietary fibres consummed per day
- no analgesic treatment
- no treatment for intestinal transit
Who cannot join
- subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
- excessive consumption of alcohol or tobacco
- participating to another clinical study
- pregnant women
- antidepressor or anxiolytic treatment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients
Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fructo-oligosaccharides, Maltodextrins
- 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.
Fructo-oligosaccharidesDietary supplement
Dietary supplementation for 4 weeks
MaltodextrinsDietary supplement
Dietary supplementation for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fructo-oligosaccharides Receives: Dietary Supplement: Fructo-oligosaccharides |
| 2 | Placebo comparator | Maltodextrins Receives: Dietary Supplement: Maltodextrins |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectal sensitivity
Measured: 4 weeks
Secondary outcomes (1)
taxonomic composition of intestinal microbiota
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startMar 2009
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beghin-Meiji
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michel Dapoigny, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806104
- Sponsor's protocol ID
- FOS_QLV2
- Status last verified
- Jan 2011
- First submitted
- 9 Dec 2008
- Last updated
- 17 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients
- ClinicalTrials.gov ID
- NCT00806104
- Acronym / sponsor ID
- FOS_QLV2
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beghin-MeijiIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Dec 2008 (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.
Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Fructo-oligosaccharidesFructo-oligosaccharides |
| 2 | Placebo comparator | Dietary Supplement: MaltodextrinsMaltodextrins |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- IBS subjects according to Rome III criteria
- Incomfort below or equivalent to 30mmHg during Tensostat test
- between 18 and 60 years
- no antibiotic treatment for the last 2 months
- less than 20g of dietary fibres consummed per day
Key exclusion criteria (5 listed)
- subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
- excessive consumption of alcohol or tobacco
- participating to another clinical study
- pregnant women
- antidepressor or anxiolytic treatment
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 |
|---|---|---|
| Fructo-oligosaccharidesDietary supplementation for 4 weeks | Dietary supplement | 1 |
| MaltodextrinsDietary supplementation for 4 weeks | Dietary supplement | 2 |
Primary outcome
rectal sensitivity
Time frame: 4 weeks
1 secondary outcome
taxonomic composition of intestinal microbiota
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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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, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructo-oligosaccharides and Maltodextrins in people with Irritable Bowel Syndrome, run by Beghin-Meiji at 2 sites in 2 countries.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 17 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 2 sites in France, Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rectal sensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2011.