Irritable Bowel SyndromeNCT00742118
Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel
A study testing Colic biopsies in people with Irritable Bowel Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate: 1. paracellular permeability in colonic biopsies of IBS patient 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Colic biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2008to 24 Aug 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients needing coloscopy
Who cannot join
- Disrupted coagulation results
- Cancer even healed
- Known food allergy.
- Alcohol consumption >30g/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the entérique Nervous System During the Syndrome of the Irritable Bowel
Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate:
- paracellular permeability in colonic biopsies of IBS patient
- the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Colic biopsies
- 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.
Colic biopsiesProcedure or surgery
Also called endoscopic biopsy
colic biopsies and analysis
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | patient with chronic inflammatory intestinal disease Receives: Procedure: Colic biopsies |
| 3 | Other | patient having no symptoms Receives: Procedure: Colic biopsies |
| 1 | Experimental | patient with irritable bowel syndrome Receives: Procedure: Colic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Para-cellular permeability
Measured: at time=0
Gap junction protein expression
Measured: at time=0
Inflammation molecule expression
Measured: at time=0
Digestive discomfort degree
Measured: at time=0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study start13 Feb 2008
- Primary completion15 Sep 2014
- Study completion24 Aug 2016
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.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Thierry PICHE, PhD, Principal investigator, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742118
- Sponsor's protocol ID
- 05-API-08
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2008
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the entérique Nervous System During the Syndrome of the Irritable Bowel
- ClinicalTrials.gov ID
- NCT00742118
- Acronym / sponsor ID
- 05-API-08
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 13 Feb 2008 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 27 Aug 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.
Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate:
- paracellular permeability in colonic biopsies of IBS patient
- the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Procedure: Colic biopsiespatient with chronic inflammatory intestinal disease |
| 3 | Other | Procedure: Colic biopsiespatient having no symptoms |
| 1 | Experimental | Procedure: Colic biopsiespatient with irritable bowel syndrome |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients needing coloscopy
Key exclusion criteria (4 listed)
- Disrupted coagulation results
- Cancer even healed
- Known food allergy.
- Alcohol consumption >30g/day
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 |
|---|---|---|
| Colic biopsiesAlso: endoscopic biopsycolic biopsies and analysis | Procedure or surgery | 1, 2, 3 |
Primary outcome
Para-cellular permeability
Time frame: at time=0
Gap junction protein expression
Time frame: at time=0
Inflammation molecule expression
Time frame: at time=0
Digestive discomfort degree
Time frame: at time=0
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 16 Jun 2026.
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RecruitingPhase 2
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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.
Thierry PICHE, PhD principal investigator
Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colic biopsies in people with Irritable Bowel Syndrome, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 4 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 16 Jun 2026. 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?
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?
Para-cellular permeability (time frame: at time=0). The study lists 4 primary outcomes in all. 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 16 Jun 2026.