Irritable Bowel SyndromeNCT06792838
Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration
A study testing Confocal Laser Endomicroscopy in people with Irritable Bowel Syndrome and Food Allergy, run by Cook Children's Health Care System.
Trial summary
The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Irritable Bowel Syndrome, Food Allergy
- What is being tested?
- Confocal Laser Endomicroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Sep 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be included in the study
- Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.
- A negative or very low/low levels of Ig-E food allergy panel or negative skin prick test
- Negative celiac disease work up
Who cannot join
- If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.
- Pregnant or nursing at the time of CLE.
- Known allergy to fluorescein.
- Impaired renal function tests.
- Active GI bleeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Ambispective Evaluation of Atypical Food Allergies In-vivo Utilizing Confocal Laser Endomicroscopy in Pediatric and Adult Patients
The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low/low levels of Immunoglobulin E (IgE) serological tests.
Read the detailed description
The prevalence of food allergies in children and adults are estimated to be 5-7% and 11% in the US respectively. The mechanism underlying food allergies are either IgE mediated, non-IgE mediated or both.
CLE is a diagnostic modality that allows for high-resolution imaging of the GI tract, providing real-time in-vivo visualization of the mucosal and submucosal microstructure similar to histology. What differentiates it from conventional histology wherein tissue is sectioned vertically, is that the endomicroscopic images are a single optical plane parallel to the tissue surface, yielding multiple optical sections of successive depths of greater precision.
Recent studies demonstrated the utility of CLE in the evaluation of gastroenterological diseases, specifically for inflammatory bowel disease. Although histological evaluation continues to remain the gold standard, CLE has potential applications in surveillance, targeted biopsies and disease management of GI conditions such as celiac disease, eosinophilic disease and more recently in patients with Irritable Bowel Syndrome (IBS) with atypical food allergies that are non-IgE mediated.
A common observation in patients with IBS using CLE include increased epithelial gaps when compared to healthy controls. It is proposed that there is an alteration in the epithelial barrier which in healthy state, prevents the microbes and antigens from entering the body. Increased epithelial cell extrusions result in altered intestinal permeability, which is commonly seen in IBS. The utility of CLE in visualizing the integrity of the intestinal barrier in children with atypical presentation of food allergies is unknown. The ability to observe these dynamic changes in real-time is promising in the management of IBS.
Endomicroscopic diagnosis of food-induced allergy-like reactions was first used as a guideline in the implementation of the food intolerance testing performed as part of this protocol.
- Conditions
- Irritable Bowel Syndrome, Food Allergy
- Being tested
- Confocal Laser Endomicroscopy
- Medical subject headings
- Irritable Bowel Syndrome, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser EndomicroscopyDevice
- The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously.
- The duodenal mucosa is assessed at a minimum of four sites (20 seconds each
- The first potential allergen will be sprayed via catheter onto the mucosa.
- After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBS | Experimental | CLE will be used to observe changes in the duodenal mucosa once the allergen is introduced. Receives: Device: Confocal Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with IBS symptoms with evidence of epithelial barrier dysfunction
Measured: Day 1
Secondary outcomes (1)
Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scale Questionnaire
The Pediatric Quality of Life Inventory (PedsQL) Questionnaire is an instrument used to measure quality of life in children and adolescents ages 2-18 that can be used by children to self-report or by parents as a proxy. PedsQL Gastrointestinal Symptoms Scales is a specific module of the PedsQL containing 58 items across 10 gastrointestinal symptom scales. Participants rate problems on a scale of 0 (never a problem) to 4 (almost always a problem).
Items are reverse-scored and linearly transformed to a 0-100 scale, thus higher scores indicate better GI-specific Health-Related Quality of Life (HRQOL) and hence lower symptoms.
Measured: Baseline, 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2033 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Model description
- This study is not an interventional study; however, it uses an FDA approved investigational device.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Children's Health Care System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska Medical Center and Children's Hospital & Medical Center, Stanford University, Metrodora Institute, Meliora Bio ApS
- Responsible party
- Sponsor
- Investigators
- Clifton Huang, MD, Principal investigator, Cook Children's Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792838
- Sponsor's protocol ID
- 2024-073
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilaver LA, Thivalapill N, Zaslavsky J, Galic I, Gupta RS, Nimmagadda SR. Prevalence and correlates of co-occurring allergies in a US food allergy patient registry. J Allergy Clin Immunol Pract. 2023 Jan;11(1):332-334.e1. doi: 10.1016/j.jaip.2022.10.006. Epub 2022 Oct 19. No abstract available.
PubMed 36272719Buchner AM, Wallace MB. Endomicroscopy and Molecular Tools to Evaluate Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2016 Oct;26(4):657-68. doi: 10.1016/j.giec.2016.06.002. Epub 2016 Aug 16.
PubMed 27633594Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.
PubMed 26513619Fritscher-Ravens A, Schuppan D, Ellrichmann M, Schoch S, Rocken C, Brasch J, Bethge J, Bottner M, Klose J, Milla PJ. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014 Nov;147(5):1012-20.e4. doi: 10.1053/j.gastro.2014.07.046. Epub 2014 Jul 30.
PubMed 25083606Turcotte JF, Kao D, Mah SJ, Claggett B, Saltzman JR, Fedorak RN, Liu JJ. Breaks in the wall: increased gaps in the intestinal epithelium of irritable bowel syndrome patients identified by confocal laser endomicroscopy (with videos). Gastrointest Endosc. 2013 Apr;77(4):624-30. doi: 10.1016/j.gie.2012.11.006. Epub 2013 Jan 26.
PubMed 23357497Rath T, Dieterich W, Katscher-Murad C, Neurath MF, Zopf Y. Cross-sectional imaging of intestinal barrier dysfunction by confocal laser endomicroscopy can identify patients with food allergy in vivo with high sensitivity. Sci Rep. 2021 Jun 17;11(1):12777. doi: 10.1038/s41598-021-92262-4.
PubMed 34140591Fritscher-Ravens A, Pflaum T, Mosinger M, Ruchay Z, Rocken C, Milla PJ, Das M, Bottner M, Wedel T, Schuppan D. Many Patients With Irritable Bowel Syndrome Have Atypical Food Allergies Not Associated With Immunoglobulin E. Gastroenterology. 2019 Jul;157(1):109-118.e5. doi: 10.1053/j.gastro.2019.03.046. Epub 2019 May 15.
PubMed 31100380Ray K. Endoscopy: a window into the gut--real-time visualization of the effects of food intolerance using confocal laser endomicroscopy. Nat Rev Gastroenterol Hepatol. 2014 Oct;11(10):578. doi: 10.1038/nrgastro.2014.147. Epub 2014 Aug 19. No abstract available.
PubMed 25134512
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Ambispective Evaluation of Atypical Food Allergies In-vivo Utilizing Confocal Laser Endomicroscopy in Pediatric and Adult Patients
- ClinicalTrials.gov ID
- NCT06792838
- Acronym / sponsor ID
- 2024-073
- Conditions
- Irritable Bowel Syndrome, Food Allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cook Children's Health Care SystemUniversity, hospital or other
- Collaborators
- University of Nebraska Medical Center and Children's Hospital & Medical Center, Stanford University, Metrodora Institute, Meliora Bio ApS
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 27 Jan 2025 (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.
The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low/low levels of Immunoglobulin E (IgE) serological tests.
Detailed description
The prevalence of food allergies in children and adults are estimated to be 5-7% and 11% in the US respectively. The mechanism underlying food allergies are either IgE mediated, non-IgE mediated or both.
CLE is a diagnostic modality that allows for high-resolution imaging of the GI tract, providing real-time in-vivo visualization of the mucosal and submucosal microstructure similar to histology. What differentiates it from conventional histology wherein tissue is sectioned vertically, is that the endomicroscopic images are a single optical plane parallel to the tissue surface, yielding multiple optical sections of successive depths of greater precision.
Recent studies demonstrated the utility of CLE in the evaluation of gastroenterological diseases, specifically for inflammatory bowel disease. Although histological evaluation continues to remain the gold standard, CLE has potential applications in surveillance, targeted biopsies and disease management of GI conditions such as celiac disease, eosinophilic disease and more recently in patients with Irritable Bowel Syndrome (IBS) with atypical food allergies that are non-IgE mediated.
A common observation in patients with IBS using CLE include increased epithelial gaps when compared to healthy controls. It is proposed that there is an alteration in the epithelial barrier which in healthy state, prevents the microbes and antigens from entering the body. Increased epithelial cell extrusions result in altered intestinal permeability, which is commonly seen in IBS. The utility of CLE in visualizing the integrity of the intestinal barrier in children with atypical presentation of food allergies is unknown. The ability to observe these dynamic changes in real-time is promising in the management of IBS.
Endomicroscopic diagnosis of food-induced allergy-like reactions was first used as a guideline in the implementation of the food intolerance testing performed as part of this protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is not an interventional study; however, it uses an FDA approved investigational device.
| Arm | Type | Receives |
|---|---|---|
| Patients with IBS | Experimental | Device: Confocal Laser EndomicroscopyCLE will be used to observe changes in the duodenal mucosa once the allergen is introduced. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must meet all of the following criteria to be included in the study
- Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.
- A negative or very low/low levels of Ig-E food allergy panel or negative skin prick test
- Negative celiac disease work up
Key exclusion criteria (5 listed)
- If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.
- Pregnant or nursing at the time of CLE.
- Known allergy to fluorescein.
- Impaired renal function tests.
- Active GI bleeding.
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 |
|---|---|---|
| Confocal Laser Endomicroscopy1. The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously. 2. The duodenal mucosa is assessed at a minimum of four sites (20 seconds each 3. The first potential allergen will be sprayed via catheter onto the mucosa. 4. After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient. | Device | Patients with IBS |
Primary outcome
Number of subjects with IBS symptoms with evidence of epithelial barrier dysfunction
Time frame: Day 1
1 secondary outcome
Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scale Questionnaire
Time frame: Baseline, 1 month, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 36272719Bilaver LA, Thivalapill N, Zaslavsky J, Galic I, Gupta RS, Nimmagadda SR. Prevalence and correlates of co-occurring allergies in a US food allergy patient registry. J Allergy Clin Immunol Pract. 2023 Jan;11(1):332-334.e1. doi: 10.1016/j.jaip.2022.10.006. Epub 2022 Oct 19. No abstract available.
- Background: PubMed 27633594Buchner AM, Wallace MB. Endomicroscopy and Molecular Tools to Evaluate Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2016 Oct;26(4):657-68. doi: 10.1016/j.giec.2016.06.002. Epub 2016 Aug 16.
- Background: PubMed 26513619Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.
- Background: PubMed 25083606Fritscher-Ravens A, Schuppan D, Ellrichmann M, Schoch S, Rocken C, Brasch J, Bethge J, Bottner M, Klose J, Milla PJ. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014 Nov;147(5):1012-20.e4. doi: 10.1053/j.gastro.2014.07.046. Epub 2014 Jul 30.
- Background: PubMed 23357497Turcotte JF, Kao D, Mah SJ, Claggett B, Saltzman JR, Fedorak RN, Liu JJ. Breaks in the wall: increased gaps in the intestinal epithelium of irritable bowel syndrome patients identified by confocal laser endomicroscopy (with videos). Gastrointest Endosc. 2013 Apr;77(4):624-30. doi: 10.1016/j.gie.2012.11.006. Epub 2013 Jan 26.
- Background: PubMed 34140591Rath T, Dieterich W, Katscher-Murad C, Neurath MF, Zopf Y. Cross-sectional imaging of intestinal barrier dysfunction by confocal laser endomicroscopy can identify patients with food allergy in vivo with high sensitivity. Sci Rep. 2021 Jun 17;11(1):12777. doi: 10.1038/s41598-021-92262-4.
- Background: PubMed 31100380Fritscher-Ravens A, Pflaum T, Mosinger M, Ruchay Z, Rocken C, Milla PJ, Das M, Bottner M, Wedel T, Schuppan D. Many Patients With Irritable Bowel Syndrome Have Atypical Food Allergies Not Associated With Immunoglobulin E. Gastroenterology. 2019 Jul;157(1):109-118.e5. doi: 10.1053/j.gastro.2019.03.046. Epub 2019 May 15.
- Background: PubMed 25134512Ray K. Endoscopy: a window into the gut--real-time visualization of the effects of food intolerance using confocal laser endomicroscopy. Nat Rev Gastroenterol Hepatol. 2014 Oct;11(10):578. doi: 10.1038/nrgastro.2014.147. Epub 2014 Aug 19. No abstract available.
- 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.
Clifton Huang, MD principal investigator
Cook Children's Health Care System
Questions about this trial
What is this clinical trial studying?
A study testing Confocal Laser Endomicroscopy in people with Irritable Bowel Syndrome and Food Allergy, run by Cook Children's Health Care System.
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 4 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: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumith Roy, MBBS, MPH (682-885-1790, Sumith.Roy@cookchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with IBS symptoms with evidence of epithelial barrier dysfunction (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792838, which also lists 8 linked publications.
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 24 Feb 2025.