Irritable Bowel SyndromeSIIMPANCT02550704
Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients
A study testing Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
Trial summary
Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2016to 20 May 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS-Diarrhoea according to Rome III criteria,
- Faecal calprotectin ≤200 µg/g in the last two months
- Effective contraception since 1 month for women in childbearing age
Who cannot join
- Patients with organic and/or inflammatory digestive disease
- IBS with constipation or alternating
- Treatment such as anti-inflammatory, probiotic in the last three months
- Patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments
- Small intestinal bacterial overgrowth (identified by a glucose breath test)
- Hypersensitivity to Normacol
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- Severe renal failure
- Anal pathology (anal fissure, hemorrhoidal thrombosis)
- Pregnant or breastfeeding women
- Person with administrative or judicial decision or under legal protection measure
- Patient participating in another trial in the last two weeks
- Diet based in grapes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea
Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.
Read the detailed description
Irritable bowel syndrome (IBS) is a common functional disorder which affect around 10% of the general population. Abdominal pain and discomfort are associated with transit disorders (diarrhea, constipation, alternating). IBS is defined by Rome III criteria.
For clinicians, IBS remains difficult to treat while its pathophysiology remains not completely understood. Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three abnormalities found in IBS patients. Visceral hypersensitivity is present in 60% of the patients, while intestinal permeability is increased in a subgroup of IBS with diarrhea. Low grade inflammation could be identify with faecal calprotectin dosage. The link between this three abnormalities is not clear.
The goal of our study is to describe the prevalence of these three abnormalities in IBS-Diarrhea population and to look for a correlation between low grade inflammation, visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability
- Keywords
- Irritable Bowel syndrome, Intestinal permeability, Visceral hypersensitivity, Low grade inflammation
- 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.
Colonoscopy with eleven biopsies in the left colon to assess intestinal permeabilityProcedure or surgery
Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin, occludin and ZO-1.
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Syndrome with diarrhea | Experimental | Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability. Intestinal permeability is not routinely performed and is assessed in colonic biopsies (occludin, claudin and ZO-1 by western blot, qPCR and immunofluorescence) Receives: Procedure: Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occludin level expression in left colonic biopsies
Occludin expression is measured using western blot (for proteins), Quantitative Real Time Polymerase Chain Reaction (q RT-PCR) (RNA) and IF (for localization)
Measured: day 1
Faecal calprotectin level
Level is assessed on stool sample by ELISA kit in µg/g
Measured: day 1
Secondary outcomes (6)
Claudin level expression in left colonic biopsies
Claudin expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)
Measured: day 1
Zonula Occludens (ZO)-1 level expression
ZO-1 expression is measured using western blot (for proteins), q RT-PCR (for RNA) and IF (for localization)
Measured: day 1
Pression pain threshold by rectal barostat
Pression pain threshold is measured in mmHg during rectal barostat.
Measured: day 1
Quality of life by GIQLI
Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI)
Measured: day 1
Abdominal symptoms
Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
Measured: day 1
Anxiety and depression level
Anxiety and depression are assessed with the Hospital anxiety and depression scale.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start20 May 2016
- Primary completion20 May 2021
- Study completion20 May 2021
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 University Hospital, RouenThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
- Investigators
- Chloé Melchior, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550704
- Sponsor's protocol ID
- 2015/079/HP
- Acronym
- SIIMPA
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2015
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea
- ClinicalTrials.gov ID
- NCT02550704
- Acronym / sponsor ID
- SIIMPA / 2015/079/HP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel syndrome, Intestinal permeability, Visceral hypersensitivity, Low grade inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Study start
- 20 May 2016 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 15 Sep 2015 (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.
Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.
Detailed description
Irritable bowel syndrome (IBS) is a common functional disorder which affect around 10% of the general population. Abdominal pain and discomfort are associated with transit disorders (diarrhea, constipation, alternating). IBS is defined by Rome III criteria.
For clinicians, IBS remains difficult to treat while its pathophysiology remains not completely understood. Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three abnormalities found in IBS patients. Visceral hypersensitivity is present in 60% of the patients, while intestinal permeability is increased in a subgroup of IBS with diarrhea. Low grade inflammation could be identify with faecal calprotectin dosage. The link between this three abnormalities is not clear.
The goal of our study is to describe the prevalence of these three abnormalities in IBS-Diarrhea population and to look for a correlation between low grade inflammation, visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irritable Bowel Syndrome with diarrhea | Experimental | Procedure: Colonoscopy with eleven biopsies in the left colon to assess intestinal permeabilityColonoscopy with eleven biopsies in the left colon to assess intestinal permeability. Intestinal permeability is not routinely performed and is assessed in colonic biopsies (occludin, claudin and ZO-1 by western blot, qPCR and immunofluorescence) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IBS-Diarrhoea according to Rome III criteria,
- Faecal calprotectin ≤200 µg/g in the last two months
- Effective contraception since 1 month for women in childbearing age
Key exclusion criteria (12 listed)
- Patients with organic and/or inflammatory digestive disease
- IBS with constipation or alternating
- Treatment such as anti-inflammatory, probiotic in the last three months
- Patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments
- Small intestinal bacterial overgrowth (identified by a glucose breath test)
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 |
|---|---|---|
| Colonoscopy with eleven biopsies in the left colon to assess intestinal permeabilityEleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin, occludin and ZO-1. | Procedure or surgery | Irritable Bowel Syndrome with diarrhea |
Primary outcome
Occludin level expression in left colonic biopsies
Time frame: day 1
Occludin expression is measured using western blot (for proteins), Quantitative Real Time Polymerase Chain Reaction (q RT-PCR) (RNA) and IF (for localization)
Faecal calprotectin level
Time frame: day 1
Level is assessed on stool sample by ELISA kit in µg/g
6 secondary outcomes
Claudin level expression in left colonic biopsies
Time frame: day 1
Zonula Occludens (ZO)-1 level expression
Time frame: day 1
Pression pain threshold by rectal barostat
Time frame: day 1
Quality of life by GIQLI
Time frame: day 1
Abdominal symptoms
Time frame: day 1
Anxiety and depression level
Time frame: day 1
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 26 May 2022.
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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.
Chloé Melchior, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability in people with Irritable Bowel Syndrome, run by University Hospital, Rouen 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 3 inclusion and 12 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 26 May 2022. 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?
Occludin level expression in left colonic biopsies (time frame: day 1). The study lists 2 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 26 May 2022.