An interventional study of Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability in Irritable Bowel Syndrome, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Screening
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 34 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
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)
Procedure: Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability
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.
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)
Time frame: day 1
Faecal calprotectin level
Level is assessed on stool sample by ELISA kit in µg/g
Time frame: day 1
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)
Time frame: 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)
Time frame: day 1
Pression pain threshold by rectal barostat
Pression pain threshold is measured in mmHg during rectal barostat.
Time frame: 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)
Time frame: day 1
Abdominal symptoms
Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
Time frame: day 1
Anxiety and depression level
Anxiety and depression are assessed with the Hospital anxiety and depression scale.
Time frame: day 1
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen