Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05072665 |
| Other study ID # |
2021-A01267-34 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
May 4, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Clinique du Trocadéro |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 (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
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.
