Fast Allergy Sensitivity Test

NCT05072665 | Completed

• 1 other identifier: 2021-A01267-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (4)

• Observation, at the time of the endomicroscopy procedure, of ruptures / leaks in the mucous membranes and intercellular extravasation of plasma fluid labeled with fluorescein in the intercellular space

  day 1

• SCORE ROME IV

  QUESTIONNARY

  DAYS 28

• SCORE ROME IV

  QUESTIONNARY

  2 months

• SCORE ROME IV

  QUESTIONNARY

  6 months

Secondary Outcomes (4)

• SCORE OBS-SSS

  days 28

• SCORE OBS-SSS

  2months

• SCORE OBS-SSS

  6 months

• RESULT OH THE DIET

  6 MONTHS

Study Arms (1)

PATIENT WITH Irritable Bowel Syndrome

EXPERIMENTAL

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

Interventions

HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE DEVICE

HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE

PATIENT WITH Irritable Bowel Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique du Trocadéro: lead

Study Sites (1)

clinique du Trocadero

Paris, 75016, France

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: October 11, 2021
• Study Start: September 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 4, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)