Fast Allergy Sensitivity Test
Irritable Bowel Syndrome (IBS), or functional colopathy, is a chronic disease that affects 10% to 20% of the world's population.This syndrome is characterized by chronic abdominal pain or discomfort as well as a change in bowel habits (constipation or diarrhea) in the absence of structural or metabolic abnormalities (e.g. celiac disease, Crohn's disease). These symptoms have an impact on the quality of life of these patients who must therefore integrate the management of their disease into their daily life.IBS is subdivided into 3 subtypes according to the predominant symptom: the IBS-D subtype which groups together patients who have a predominance of diarrheal episodes, the IBS-C subtype which groups together patients who have a predominance of '' episodes of constipation and finally the IBS-M subtype which includes patients whose two symptoms mentioned above are observed without predominance
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Patients over 18 years old.
- - Diagnosis of irritable bowel syndrome according to the ROME IV classification.
- - Negative blood test: determination of IgE; anti-transglutaminase IgA assay (celiac disease) - Symptoms potentially related to a food allergy.
- - Sufficient cooperation and understanding to comply with the requirements of the study with a post-Cellvizio medical examination at 2 weeks, 2 months and 6 months.
- - Patients under 18.
- - Patient benefiting from a legal protection measure (curatorship, guardianship, etc.) - Pregnant or breastfeeding woman.
- - Known allergy to fluorescein.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Clinique du Trocadéro|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
In 2014, Fritscher-Ravens et al., Described for the first time the value of endomicroscopy in the diagnosis of food allergies by observing the reaction of the duodenal mucosa to food allergens in patients with IBS. They assessed the structural and functional changes that were occurring in the intestinal lining in vivo and noted the following changes at the cellular level:
- - The layers of epithelial cells break down and are removed forming voids and inducing an immediate increase in the fluid permeability of the duodenal mucosa.
- - These changes were usually seen between 2 min and 4 min after exposure to the allergen.
Experimental: PATIENT WITH Irritable Bowel Syndrome
2.5 ml of 10% fluorescein (SERB) will be administered to the patient intravenously. after the fluorescein injection. A first food allergen will be applied to the duodenal mucosa starting with the most distal part of the duodenum. After 2 minutes following the application of the allergen, observation using the endomicroscopy system can begin by applying the GastroFlex ™ UHD probe to the duodenal mucosa where the allergen has been projected. . Observation will last up to 3 minutes per site observed. If no reaction is observed, the same manipulation will be carried out using a new allergen. If the observed reaction is positive, the test will be stopped
Device: - HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE
HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
clinique du Trocadero
Paris, , 75016
benkessou, project manager