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Fast Allergy Sensitivity Test

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Patients under 18.
  • - Patient benefiting from a legal protection measure (curatorship, guardianship, etc.) - Pregnant or breastfeeding woman.
  • - Known allergy to fluorescein.
- Digestive cancer (stomach cancer colon rectal cancer)

Trial Details

Trial ID:

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.

NCT05072665
Phase

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.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Clinique du Trocadéro
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Additional Details

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.
As a result, the contrast agent penetrates the lumen, widening the space between the villi and changing the appearance from black to white.
  • - These changes were usually seen between 2 min and 4 min after exposure to the allergen.
This procedure, called FAST (Food Allergy Sensitivity Test), has since been used routinely in certain centers in Germany. However, few studies have been published that have shown the reproducibility of these results as well as the performance of this new test. The study that the investigators propose to conduct is a prospective multicenter pilot study conducted in the Trocadero Clinic. 1. Pre-test consultation The patients will first be seen by a nutritionist. During this consultation, eligible patients will be offered, in addition to endoscopy performed in current practice, the possibility of performing the FAST test during endoscopy. Up to 7 days before the operation, a questionnaire allowing the assessment of the severity of symptoms (IBS-SSS) will be provided to the patient who has agreed to participate in the study. The answers to the questionnaire will be used as a reference to assess the evolution of symptoms if a food exclusion diet were to be put in place following the procedure. Finally, two to three days before the FAST test, the patient will be asked to follow an exclusion diet and consume only hypoallergenic nutritional foods: rice, potatoes, olive oil, salt. 2 Carrying out the test Before the start of the test, a standard high-end endoscopy will be performed to look for any signs of structural mucosal abnormalities that suggest gastrointestinal disease. In the event of a mucosal abnormality observed on endoscopy, the CLE FAST procedure will be canceled. In the case of mild reflux disease, the test may be done. Prior to the first challenge, 2.5 ml of 10% fluorescein (SERB) will be administered to the patient intravenously. Before any challenge and after the fluorescein injection, to establish a comparison image, a first acquisition with the endomicroscopy system of the duodenal mucosa will be carried out on a minimum of 4 sites (approximately 20 seconds each) to verify the integrity of the mucosa. During the acquisition of the reference sequences and during all subsequent acquisitions, areas of the mucosa that show bleeding and other visible signs of inflammation will not be imaged in order to avoid false positives. Once the reference images have been acquired, 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. The test can be performed using up to 5 different allergens as long as the total time after fluorescein injection does not exceed 30min.

Arms & Interventions

Arms

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

Interventions

Device: - HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE

HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE

Contact a Trial Team

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International Sites

clinique du Trocadero, Paris, France

Status

Recruiting

Address

clinique du Trocadero

Paris, , 75016

Site Contact

benkessou, project manager

bbenkessou@hexagone-sante-paris.fr

0764486016

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