Irritable Bowel SyndromeBISIINCT02877654
Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?
A study testing colonoscopy with 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
Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. 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 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
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2017to 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, IBS-constipation or alternating with recent worsening of symptoms, according to Rome III criteria
- 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 without clinical warning sign
- Treatment such as anti-inflammatory, probiotic in the last three months
- Severe renal failure
- Hypersensitivity to Normacol
- Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Intestinal Barrier in Irritable Bowel Syndrome Patients : Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins ?
Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. Currently, no test used in clinical practice could assess intestinal permeability.
We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.
Read the detailed description
The goal of our study is to look for a correlation between plasmatic zonulin and increased colonic permeability (assessed by the expression of intestinal tight junction proteins by western blot) in IBS patients and to look for a role of intestinal low-grade inflammation and microbiota.
Population :
IBS patients with diarrhoea or IBS with constipation or mixed with worsening of symptoms
Outcomes measures :
Plasmatic zonulin (ELISA kit) Occludin expression in colonic biopsies (western blot)
- Conditions
- Irritable Bowel Syndrome
- Being tested
- colonoscopy with biopsies in the left colon to assess intestinal permeability
- Keywords
- Plasmatic zonulin, Irritable Bowel Syndrome, Intestinal permeability
- 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 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.
One blood sample is taken to assess plasmatic zonulin (ELISA kit).
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Syndrome | Experimental | Not described Receives: Procedure: colonoscopy with 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), q RT-PCT (for RNA) and IF (for localization).
Plasmatic zonulin is measured in plasma using ELISA kit.
Measured: day 1
plasmatic zonulin expression
Plasmatic zonulin expression is done using ELISA kit
Measured: day 1
Secondary outcomes (5)
Claudin and ZO-1 level expression in left colonic biopsies
Claudin and ZO-1 expression is measured using western blot (for proteins), q RT-PCT (for 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
Quality of life (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 levels
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 posted24 Aug 2016 (estimated)
- Study start2 Feb 2017
- 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.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé Melchior, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877654
- Sponsor's protocol ID
- 2015/174/HP
- Acronym
- BISII
- Status last verified
- Sep 2021
- First submitted
- 16 Aug 2016
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Assessment of Intestinal Barrier in Irritable Bowel Syndrome Patients : Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins ?
- ClinicalTrials.gov ID
- NCT02877654
- Acronym / sponsor ID
- BISII / 2015/174/HP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Plasmatic zonulin, Irritable Bowel Syndrome, Intestinal permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 24 Aug 2016 (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.
Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. Currently, no test used in clinical practice could assess intestinal permeability.
We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.
Detailed description
The goal of our study is to look for a correlation between plasmatic zonulin and increased colonic permeability (assessed by the expression of intestinal tight junction proteins by western blot) in IBS patients and to look for a role of intestinal low-grade inflammation and microbiota.
Population :
IBS patients with diarrhoea or IBS with constipation or mixed with worsening of symptoms
Outcomes measures :
Plasmatic zonulin (ELISA kit) Occludin expression in colonic biopsies (western blot)
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 | Experimental | Procedure: colonoscopy with biopsies in the left colon to assess intestinal permeability |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBS-Diarrhoea, IBS-constipation or alternating with recent worsening of symptoms, according to Rome III criteria
- Effective contraception since 1 month for women in childbearing age
Key exclusion criteria (10 listed)
- Patients with organic and/or inflammatory digestive disease
- IBS with constipation or alternating without clinical warning sign
- Treatment such as anti-inflammatory, probiotic in the last three months
- Severe renal failure
- Hypersensitivity to Normacol
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 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. One blood sample is taken to assess plasmatic zonulin (ELISA kit). | Procedure or surgery | Irritable Bowel Syndrome |
Primary outcome
occludin level expression in left colonic biopsies
Time frame: day 1
occludin expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization). Plasmatic zonulin is measured in plasma using ELISA kit.
plasmatic zonulin expression
Time frame: day 1
Plasmatic zonulin expression is done using ELISA kit
5 secondary outcomes
Claudin and ZO-1 level expression in left colonic biopsies
Time frame: day 1
Faecal calprotectin level
Time frame: day 1
Quality of life (GIQLI)
Time frame: day 1
Abdominal symptoms
Time frame: day 1
Anxiety and depression levels
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.
- Individual participant dataSharing planned: No
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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 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 2 inclusion and 10 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.