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Food AllergyFASTNCT05072665

Fast Allergy Sensitivity Test

A study testing HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE in people with Food Allergy, run by Clinique du Trocadéro at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Food Allergy
What is being tested?
HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
1 Sep 2021to 4 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site
  • clinique du Trocadero

    Paris, 75016

Other trials in France

About this study

Official title: EFFECT OF FOOD ALLERGENS ON DUODENAL MUCOSAUS BY CONFOCAL ENDOSCOPIC IMAGING Cellvizio

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

Read the detailed description

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.

Conditions
Food Allergy
Being tested
HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE
Medical subject headings
Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIGH ECHOENDOSCOPY WITH THE FAST PROCEDUREDevice

    HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE

Study groups in NCT05072665
Study groupRoleWhat they receive
PATIENT WITH Irritable Bowel SyndromeExperimental2.5 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
Receives: Device: HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: day 1

  2. SCORE ROME IV

    QUESTIONNARY

    Measured: DAYS 28

  3. SCORE ROME IV

    QUESTIONNARY

    Measured: 2 months

  4. SCORE ROME IV

    QUESTIONNARY

    Measured: 6 months

Secondary outcomes (4)
  1. SCORE OBS-SSS

    QUESTIONNARY

    Measured: days 28

  2. SCORE OBS-SSS

    QUESTIONNARY

    Measured: 2months

  3. SCORE OBS-SSS

    QUESTIONNARY

    Measured: 6 months

  4. RESULT OH THE DIET

    consultation

    Measured: 6 MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Apr 2023
  4. Study completion4 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05072665
Sponsor's protocol ID
2021-A01267-34
Acronym
FAST
Status last verified
Sep 2023
First submitted
1 Sep 2021
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE in people with Food Allergy, run by Clinique du Trocadéro at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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