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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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
- 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 group | Role | What they receive |
|---|---|---|
| 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 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.
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
SCORE ROME IV
QUESTIONNARY
Measured: DAYS 28
SCORE ROME IV
QUESTIONNARY
Measured: 2 months
SCORE ROME IV
QUESTIONNARY
Measured: 6 months
Secondary outcomes (4)
SCORE OBS-SSS
QUESTIONNARY
Measured: days 28
SCORE OBS-SSS
QUESTIONNARY
Measured: 2months
SCORE OBS-SSS
QUESTIONNARY
Measured: 6 months
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.
- First posted11 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Apr 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Clinique du Trocadéro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF FOOD ALLERGENS ON DUODENAL MUCOSAUS BY CONFOCAL ENDOSCOPIC IMAGING Cellvizio
- ClinicalTrials.gov ID
- NCT05072665
- Acronym / sponsor ID
- FAST / 2021-A01267-34
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinique du TrocadéroUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATIENT WITH Irritable Bowel Syndrome | Experimental | Device: HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE2.5 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIGH ECHOENDOSCOPY WITH THE FAST PROCEDUREHIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE | Device | PATIENT WITH Irritable Bowel Syndrome |
Primary outcome
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
SCORE ROME IV
Time frame: DAYS 28
QUESTIONNARY
SCORE ROME IV
Time frame: 2 months
QUESTIONNARY
SCORE ROME IV
Time frame: 6 months
QUESTIONNARY
4 secondary outcomes
SCORE OBS-SSS
Time frame: days 28
SCORE OBS-SSS
Time frame: 2months
SCORE OBS-SSS
Time frame: 6 months
RESULT OH THE DIET
Time frame: 6 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.