BISII: Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
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)
Arms and Interventions
|Experimental: Irritable Bowel Syndrome
Procedure: colonoscopy with 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. One blood sample is taken to assess plasmatic zonulin (ELISA kit).
Primary Outcome Measures
- occludin level expression in left colonic biopsies [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 [day 1]
Plasmatic zonulin expression is done using ELISA kit
Secondary Outcome Measures
- Claudin and ZO-1 level expression in left colonic biopsies [day 1]
Claudin and ZO-1 expression is measured using western blot (for proteins), q RT-PCT (for RNA) and IF (for localization)
- Faecal calprotectin level [day 1]
Level is assessed on stool sample by ELISA kit in µg/g
- Quality of life (GIQLI) [day 1]
Evaluation of quality of life using the validated score : french version of the Gastrointestinal Quality of Life Index (GIQLI).
- Abdominal symptoms [day 1]
Abdominal symptoms of IBS are assessed with IBS symptom severity scale.
- Anxiety and depression levels [day 1]
Anxiety and depression are assessed with the Hospital anxiety and depression scale.
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
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
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
Contacts and Locations
|1||Rouen University Hospital||Rouen||France||76031|
Sponsors and Collaborators
- University Hospital, Rouen
- Principal Investigator: Chloé Melchior, MD, Rouen University Hospital
Study Documents (Full-Text)None provided.