IBD (Inflammatory Bowel Disease)NCT07121920
Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD
A study testing Confocal Laser Endomicroscopy in people with IBD (Inflammatory Bowel Disease) and IBD, run by Cook Children's Health Care System at 2 sites in United States.
Trial summary
This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of/strongly correlated to clinical response/outcomes observed. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), IBD, IBD - Inflammatory Bowel Disease
- What is being tested?
- Confocal Laser Endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 1 Jul 2028
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must fall into one of the below categories: (i) with suspected and/or established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls
Who cannot join
- Those with previous allergy to fluorescein
- Pregnant and breastfeeding patients
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chief Research Officer contact
United States2 sites
University of Texas at Arlington
Arlington, Texas, 76010
Jon Weidanz, PhD, 817-272-6831, Weidanz@uta.edu
Cook Children's Health Care System
Fort Worth, Texas, 76104
Sumith Roy, MBBS, MPH, 682-885-1790, Sumith.Roy@cookchildrens.org
About this study
Official title: A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease
This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of/strongly correlated to clinical response/outcomes observed.
The key questions under investigation are:
Read more
Aim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy).
Aim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.
Aim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.
Read the detailed description
It is estimated that approximately 5-10% of IBD patients develop the disease during childhood or adolescence. The disease onset peaks in adolescence, while 4% of children with IBD are less than 5 years of age and 18% below 10 years of age. IBD is characterized by a prolonged course of remission and relapse.
In patients with suspected IBD, endoscopy with biopsy is the gold standard method to diagnose and assess the degree and extent of inflammation. The impairment of intact intestinal epithelial barrier function is the hallmark of IBD, further involving a cascade of molecular and cellular alterations leading to delayed mucosal wound healing.
In the past decade, several studies examined the utility of probe-based confocal laser endomicroscopy (CLE) in several diseases, including IBD. The CLE is an emerging endoscopic technology developed to obtain high magnification and high-resolution images known as "optical" biopsies of the gastrointestinal mucosal histology in real-time at the cellular and sub-cellular levels.
The advantage of CLE during endoscopy is that normal tissue can be identified in real-time with high precision. A semi-quantitative test known as the Watson score was described by to describe structural and functional barrier defects in the terminal ileum in inflammatory bowel disease using CLE.
Although the use of biologics has revolutionized the management of IBD, it is estimated that approximately 10-40% of patients with IBD on biological agents like anti-TNF such as Infliximab (IFX) are primary non-responders, with an additional 13% per patient year experiencing a secondary loss of response. In children with moderate to severe Crohn's disease, it was estimated that only 67% would continue maintenance infliximab after three-years and approximately 50% of pediatric patients on IFX require dose intensification during maintenance therapy.
Limited studies have explored the binding of fluorescent labeled biologics ex-vivo using CLE in adults with little to no published literature in children. Studies in Europe have demonstrated that greater the binding of the biologic agent to the biopsied tissue pre-treatment, was associated with increased response to treatment, which was more pronounced in Ulcerative Colitis (AUROC 83%, PPV 89%, NPV 50%). A study abstract reported to have assessed the presence of fluorescein isothicyanate (FITC) labeled Vedolizumab (VDZ) prior to initiation of VDZ therapy in five patients with Crohn's Disease refractory to anti-TNF therapy. Among the 5, two of them showed α4β7 expressing mucosal cells and were found to have a good response to subsequent treatment with VDZ. However, further details of the study were not available. Similarly, a sustained improved response to anti-TNF treatment among patients with Crohn's Disease with high membrane-bound tumor necrosis factor (mTNF) intestinal immune cells using CLE evidenced by mucosal healing was observed on follow-up endoscopy compared to those who had low mTNF levels.
We sought to pursue the proposed study for the following reasons:
- Unlike adults, IBD is more aggressive in children, for eg. impairs physical growth, impacting quality of life, in addition to the medication toxicities on top of the limited treatment options for IBD in pediatric patients.
- The current approach in the management of IBD is treat to target, to achieve mucosal healing5 as subclinical inflammation could persist (as evidenced by endoscopy or histologically active disease) even though signs and symptoms have resolved. The above testing kit couples the use of CLE to determine treatment response, which aligns with the before-mentioned therapeutic goals in the management of IBD.
- The cost of biologics are one of the major barriers to access of this promising treatment. At Cook Children's Health Care System, an average of 3-4 children/adolescents are diagnosed with Crohn's Disease or Ulcerative Colitis per week. Physicians can judiciously use biologics depending on treatment response assessed by the proposed testing kit, which will help alleviate the overall burden of cost incurred, to both the individual as well as to the healthcare system.
- Being tested
- Confocal Laser Endomicroscopy
- Keywords
- Ex-vivo, Inflammatory bowel disease, IBD, CLE, Confocal laser endomicroscopy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser EndomicroscopyDevice
Patients will undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) EGD with CLE as per standard of care. Each participant will have 3-4 mucosal biopsies taken from the terminal ileum, rectosigmoid and cecum, ideally from the most affected areas of accessible segment.
Ex vivo staining of biopsied tissue will be expanded to include FITC-labeled antibodies to cytokines IL12 and IL12/IL23 and to cytokine receptors IL12R and IL23R and possibly other cytokines, receptors and adhesion molecules. All biopsies tested for membrane bound antibodies will be done using CLE technology with artificial intelligence (AI). The cellular landscape will be characterized by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.
We will develop algorithm using AI to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pediatric patients with clinical signs and symptoms suggestive of IBD or with established diagnosis of IBD (newly diagnosed or on therapeutic management) who are scheduled to undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with CLE as part of their clinical management Receives: Device: Confocal Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of FITC tagged antibodies
Count of FITC tagged antibodies that maintain target specificity using fluorescence microplate reader. Used to establish baseline for fluorescent signal using FITC-tagged control antibody and control biopsy and IBD biopsy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for IBD (Inflammatory Bowel Disease)Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Children's Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clifton Huang, MD, Principal investigator, Cook Children's Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121920
- Sponsor's protocol ID
- 2024-083
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ghione S, Sarter H, Fumery M, Armengol-Debeir L, Savoye G, Ley D, Spyckerelle C, Pariente B, Peyrin-Biroulet L, Turck D, Gower-Rousseau C, Andre JM, Antonietti M, Aouakli A, Armand A, Aroichane I, Assi F, Aubet JP, Auxenfants E, Ayafi-Ramelot F, Bankovski D, Barbry B, Bardoux N, Baron P, Baudet A, Bazin B, Bebahani A, Becqwort JP, Benet V, Benali H, Benguigui C, Soussan BE, Bental A, Berkelmans I, Bernet J, Bernou K, Bernou-Dron C, Bertot P, Bertiaux-Vandaele N, Bertrand V, Billoud E, Biron N, Bismuth B, Bleuet M, Blondel F, Blondin V, Bohon P, Boniface E, Bonniere P, Bonvarlet E, Bonvarlet P, Boruchowicz A, Bostvironnois R, Boualit M, Bouche B, Boudaillez C, Bourgeaux C, Bourgeois M, Bourguet A, Bourienne A, Branche J, Bray G, Brazier F, Breban P, Brihier H, Brung-Lefebvre V, Bulois P, Burgiere P, Butel J, Canva JY, Canva-Delcambre V, Capron JP, Cardot F, Carpentier P, Cartier E, Cassar JF, Cassagnou M, Castex JF, Catala P, Cattan S, Catteau S, Caujolle B, Cayron G, Chandelier C, Chantre M, Charles J, Charneau T, Chavance-Thelu M, Chirita D, Choteau A, Claerbout JF, Clergue PY, Coevoet H, Cohen G, Collet R, Colombel JF, Coopman S, Corvisart J, Cortot A, Couttenier F, Crinquette JF, Crombe V, Dadamessi I, Dapvril V, Davion T, Dautreme S, Debas J, Degrave N, Dehont F, Delatre C, Delcenserie R, Delette O, Delgrange T, Delhoustal L, Delmotte JS, Demmane S, Deregnaucourt G, Descombes P, Desechalliers JP, Desmet P, Desreumaux P, Desseaux G, Desurmont P, Devienne A, Devouge E, Devred M, Devroux A, Dewailly A, Dharancy S, Di Fiore A, Djeddi D, Djedir R, Dreher-Duwat ML, Dubois R, Dubuque C, Ducatillon P, Duclay J, Ducrocq B, Ducrot F, Ducrotte P, Dufilho A, Duhamel C, Dujardin D, Dumant-Forest C, Dupas JL, Dupont F, Duranton Y, Duriez A, El Achkar K, El Farisi M, Elie C, Elie-Legrand MC, Elkhaki A, Eoche M, Evrard D, Evrard JP, Fatome A, Filoche B, Finet L, Flahaut M, Flamme C, Foissey D, Fournier P, Foutrein-Comes MC, Foutrein P, Fremond D, Frere T, Fumery M, Gallet P, Gamblin C, Ganga-Zandzou PS, Gerard R, Geslin G, Gheyssens Y, Ghossini N, Ghrib S, Gilbert T, Gillet B, Godard D, Godard P, Godchaux JM, Godchaux R, Goegebeur G, Goria O, Gottrand F, Gower P, Grandmaison B, Groux M, Guedon C, Guillard JF, Guillem L, Guillemot F, Guimber D, Haddouche B, Hakim S, Hanon D, Hautefeuille V, Heckestweiller P, Hecquet G, Hedde JP, Hellal H, Henneresse PE, Heyman B, Heraud M, Herve S, Hochain P, Houssin-Bailly L, Houcke P, Huguenin B, Iobagiu S, Ivanovic A, Iwanicki-Caron I, Janicki E, Jarry M, Jeu J, Joly JP, Jonas C, Katherin F, Kerleveo A, Khachfe A, Kiriakos A, Kiriakos J, Klein O, Kohut M, Kornhauser R, Koutsomanis D, Laberenne JE, Laffineur G, Lagarde M, Lannoy P, Lapchin J, Lapprand M, Laude D, Leblanc R, Lecieux P, Leclerc N, Le Couteulx C, Ledent J, Lefebvre J, Lefiliatre P, Legrand C, Le Grix A, Lelong P, Leluyer B, Lenaerts C, Lepileur L, Leplat A, Lepoutre-Dujardin E, Leroi H, Leroy MY, Lesage JP, Lesage X, Lesage J, Lescanne-Darchis I, Lescut J, Lescut D, Leurent B, Levy P, Lhermie M, Lion A, Lisambert B, Loire F, Louf S, Louvet A, Luciani M, Lucidarme D, Lugand J, Macaigne O, Maetz D, Maillard D, Mancheron H, Manolache O, Marks-Brunel AB, Marti R, Martin F, Martin G, Marzloff E, Mathurin P, Mauillon J, Maunoury V, Maupas JL, Mesnard B, Metayer P, Methari L, Meurisse B, Meurisse F, Michaud L, Mirmaran X, Modaine P, Monthe A, Morel L, Mortier PE, Moulin E, Mouterde O, Mudry J, Nachury M, Khac NE, Notteghem B, Ollevier V, Ostyn A, Ouraghi A, Ouvry D, Paillot B, Panien-Claudot N, Paoletti C, Papazian A, Parent B, Pariente B, Paris JC, Patrier P, Paupart L, Pauwels B, Pauwels M, Petit R, Piat M, Piotte S, Plane C, Plouvier B, Pollet E, Pommelet P, Pop D, Pordes C, Pouchain G, Prades P, Prevost A, Prevost JC, Quesnel B, Queuniet AM, Quinton JF, Rabache A, Rabelle P, Raclot G, Ratajczyk S, Rault D, Razemon V, Reix N, Revillon M, Richez C, Robinson P, Rodriguez J, Roger J, Roux JM, Rudelli A, Saber A, Savoye G, Schlosseberg P, Segrestin M, Seguy D, Serin M, Seryer A, Sevenet F, Shekh N, Silvie J, Simon V, Spyckerelle C, Talbodec N, Techy A, Thelu JL, Thevenin A, Thiebault H, Thomas J, Thorel JM, Tielman G, Tode M, Toisin J, Tonnel J, Touchais JY, Touze Y, Tranvouez JL, Triplet C, Turck D, Uhlen S, Vaillant E, Valmage C, Vanco D, Vandamme H, Vanderbecq E, Eecken VE, Vandermolen P, Vandevenne P, Vandeville L, Vandewalle A, Vandewalle C, Vaneslander P, Vanhoove JP, Vanrenterghem A, Varlet P, Vasies I, Verbiese G, Vernier-Massouille G, Vermelle P, Verne C, Vezilier-Cocq P, Vigneron B, Vincendet M, Viot J, Voiment YM, Wacrenier A, Waeghemaecker L, Wallez JY, Wantiez M, Wartel F, Weber J, Willocquet JL, Wizla N, Wolschies E, Zalar A, Zaouri B, Zellweger A, Ziade C; Epimad Group. Dramatic Increase in Incidence of Ulcerative Colitis and Crohn's Disease (1988-2011): A Population-Based Study of French Adolescents. Am J Gastroenterol. 2018 Feb;113(2):265-272. doi: 10.1038/ajg.2017.228. Epub 2017 Aug 15.
PubMed 28809388Rath T, Bojarski C, Neurath MF, Atreya R. Molecular imaging of mucosal alpha4beta7 integrin expression with the fluorescent anti-adhesion antibody vedolizumab in Crohn's disease. Gastrointest Endosc. 2017 Aug;86(2):406-408. doi: 10.1016/j.gie.2017.01.012. Epub 2017 Jan 27. No abstract available.
PubMed 28137597Iacucci M, Jeffery L, Acharjee A, Grisan E, Buda A, Nardone OM, Smith SCL, Labarile N, Zardo D, Ungar B, Hunter S, Mao R, Cannatelli R, Shivaji UN, Parigi TL, Reynolds GM, Gkoutos GV, Ghosh S. Computer-Aided Imaging Analysis of Probe-Based Confocal Laser Endomicroscopy With Molecular Labeling and Gene Expression Identifies Markers of Response to Biological Therapy in IBD Patients: The Endo-Omics Study. Inflamm Bowel Dis. 2023 Sep 1;29(9):1409-1420. doi: 10.1093/ibd/izac233.
PubMed 36378498Hyams JS, Lerer T, Griffiths A, Pfefferkorn M, Kugathasan S, Evans J, Otley A, Carvalho R, Mack D, Bousvaros A, Rosh J, Mamula P, Kay M, Crandall W, Oliva-Hemker M, Keljo D, LeLeiko N, Markowitz J; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Inflamm Bowel Dis. 2009 Jun;15(6):816-22. doi: 10.1002/ibd.20845.
PubMed 19107783Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.
PubMed 19174781Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.
PubMed 36279923Lim LG, Neumann J, Hansen T, Goetz M, Hoffman A, Neurath MF, Galle PR, Chan YH, Kiesslich R, Watson AJ. Confocal endomicroscopy identifies loss of local barrier function in the duodenum of patients with Crohn's disease and ulcerative colitis. Inflamm Bowel Dis. 2014 May;20(5):892-900. doi: 10.1097/MIB.0000000000000027.
PubMed 24691113Auzoux J, Boschetti G, Anon B, Aubourg A, Caulet M, Poisson L, Besson P, Lecomte T, Roger S, Picon L, Nancey S, Moussata D, Flourie B. Usefulness of confocal laser endomicroscopy for predicting postoperative recurrence in patients with Crohn's disease: a pilot study. Gastrointest Endosc. 2019 Jul;90(1):151-157. doi: 10.1016/j.gie.2019.02.030. Epub 2019 Mar 5.
PubMed 30849396Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Klausen P, Cartana T, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy: a novel method for prediction of relapse in Crohn's disease. Endoscopy. 2016 Apr;48(4):364-72. doi: 10.1055/s-0034-1393314. Epub 2015 Nov 19.
PubMed 26583952Kiesslich R, Duckworth CA, Moussata D, Gloeckner A, Lim LG, Goetz M, Pritchard DM, Galle PR, Neurath MF, Watson AJ. Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory bowel disease. Gut. 2012 Aug;61(8):1146-53. doi: 10.1136/gutjnl-2011-300695. Epub 2011 Nov 24.
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PubMed 22926499
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07121920
- Acronym / sponsor ID
- 2024-083
- Keywords
- Ex-vivo, Inflammatory bowel disease, IBD, CLE, Confocal laser endomicroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cook Children's Health Care SystemUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 14 Aug 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.
This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of/strongly correlated to clinical response/outcomes observed.
The key questions under investigation are:
Aim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy).
Aim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.
Aim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.
Detailed description
It is estimated that approximately 5-10% of IBD patients develop the disease during childhood or adolescence. The disease onset peaks in adolescence, while 4% of children with IBD are less than 5 years of age and 18% below 10 years of age. IBD is characterized by a prolonged course of remission and relapse.
In patients with suspected IBD, endoscopy with biopsy is the gold standard method to diagnose and assess the degree and extent of inflammation. The impairment of intact intestinal epithelial barrier function is the hallmark of IBD, further involving a cascade of molecular and cellular alterations leading to delayed mucosal wound healing.
In the past decade, several studies examined the utility of probe-based confocal laser endomicroscopy (CLE) in several diseases, including IBD. The CLE is an emerging endoscopic technology developed to obtain high magnification and high-resolution images known as "optical" biopsies of the gastrointestinal mucosal histology in real-time at the cellular and sub-cellular levels.
The advantage of CLE during endoscopy is that normal tissue can be identified in real-time with high precision. A semi-quantitative test known as the Watson score was described by to describe structural and functional barrier defects in the terminal ileum in inflammatory bowel disease using CLE.
Although the use of biologics has revolutionized the management of IBD, it is estimated that approximately 10-40% of patients with IBD on biological agents like anti-TNF such as Infliximab (IFX) are primary non-responders, with an additional 13% per patient year experiencing a secondary loss of response. In children with moderate to severe Crohn's disease, it was estimated that only 67% would continue maintenance infliximab after three-years and approximately 50% of pediatric patients on IFX require dose intensification during maintenance therapy.
Limited studies have explored the binding of fluorescent labeled biologics ex-vivo using CLE in adults with little to no published literature in children. Studies in Europe have demonstrated that greater the binding of the biologic agent to the biopsied tissue pre-treatment, was associated with increased response to treatment, which was more pronounced in Ulcerative Colitis (AUROC 83%, PPV 89%, NPV 50%). A study abstract reported to have assessed the presence of fluorescein isothicyanate (FITC) labeled Vedolizumab (VDZ) prior to initiation of VDZ therapy in five patients with Crohn's Disease refractory to anti-TNF therapy. Among the 5, two of them showed α4β7 expressing mucosal cells and were found to have a good response to subsequent treatment with VDZ. However, further details of the study were not available. Similarly, a sustained improved response to anti-TNF treatment among patients with Crohn's Disease with high membrane-bound tumor necrosis factor (mTNF) intestinal immune cells using CLE evidenced by mucosal healing was observed on follow-up endoscopy compared to those who had low mTNF levels.
We sought to pursue the proposed study for the following reasons:
- Unlike adults, IBD is more aggressive in children, for eg. impairs physical growth, impacting quality of life, in addition to the medication toxicities on top of the limited treatment options for IBD in pediatric patients.
- The current approach in the management of IBD is treat to target, to achieve mucosal healing5 as subclinical inflammation could persist (as evidenced by endoscopy or histologically active disease) even though signs and symptoms have resolved. The above testing kit couples the use of CLE to determine treatment response, which aligns with the before-mentioned therapeutic goals in the management of IBD.
- The cost of biologics are one of the major barriers to access of this promising treatment. At Cook Children's Health Care System, an average of 3-4 children/adolescents are diagnosed with Crohn's Disease or Ulcerative Colitis per week. Physicians can judiciously use biologics depending on treatment response assessed by the proposed testing kit, which will help alleviate the overall burden of cost incurred, to both the individual as well as to the healthcare system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Confocal Laser EndomicroscopyPediatric patients with clinical signs and symptoms suggestive of IBD or with established diagnosis of IBD (newly diagnosed or on therapeutic management) who are scheduled to undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with CLE as part of their clinical management |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients must fall into one of the below categories: (i) with suspected and/or established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls
Key exclusion criteria (2 listed)
- Those with previous allergy to fluorescein
- Pregnant and breastfeeding patients
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 EndomicroscopyPatients will undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) EGD with CLE as per standard of care. Each participant will have 3-4 mucosal biopsies taken from the terminal ileum, rectosigmoid and cecum, ideally from the most affected areas of accessible segment. Ex vivo staining of biopsied tissue will be expanded to include FITC-labeled antibodies to cytokines IL12 and IL12/IL23 and to cytokine receptors IL12R and IL23R and possibly other cytokines, receptors and adhesion molecules. All biopsies tested for membrane bound antibodies will be done using CLE technology with artificial intelligence (AI). The cellular landscape will be characterized by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD. We will develop algorithm using AI to predict responders versus non-responders and to further subclassify IBD patients using phenotype data. | Device | Intervention |
Primary outcome
Number of FITC tagged antibodies
Time frame: Baseline
Count of FITC tagged antibodies that maintain target specificity using fluorescence microplate reader. Used to establish baseline for fluorescent signal using FITC-tagged control antibody and control biopsy and IBD biopsy.
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 14 Aug 2025.
- Background: PubMed 28809388Ghione S, Sarter H, Fumery M, Armengol-Debeir L, Savoye G, Ley D, Spyckerelle C, Pariente B, Peyrin-Biroulet L, Turck D, Gower-Rousseau C, Andre JM, Antonietti M, Aouakli A, Armand A, Aroichane I, Assi F, Aubet JP, Auxenfants E, Ayafi-Ramelot F, Bankovski D, Barbry B, Bardoux N, Baron P, Baudet A, Bazin B, Bebahani A, Becqwort JP, Benet V, Benali H, Benguigui C, Soussan BE, Bental A, Berkelmans I, Bernet J, Bernou K, Bernou-Dron C, Bertot P, Bertiaux-Vandaele N, Bertrand V, Billoud E, Biron N, Bismuth B, Bleuet M, Blondel F, Blondin V, Bohon P, Boniface E, Bonniere P, Bonvarlet E, Bonvarlet P, Boruchowicz A, Bostvironnois R, Boualit M, Bouche B, Boudaillez C, Bourgeaux C, Bourgeois M, Bourguet A, Bourienne A, Branche J, Bray G, Brazier F, Breban P, Brihier H, Brung-Lefebvre V, Bulois P, Burgiere P, Butel J, Canva JY, Canva-Delcambre V, Capron JP, Cardot F, Carpentier P, Cartier E, Cassar JF, Cassagnou M, Castex JF, Catala P, Cattan S, Catteau S, Caujolle B, Cayron G, Chandelier C, Chantre M, Charles J, Charneau T, Chavance-Thelu M, Chirita D, Choteau A, Claerbout JF, Clergue PY, Coevoet H, Cohen G, Collet R, Colombel JF, Coopman S, Corvisart J, Cortot A, Couttenier F, Crinquette JF, Crombe V, Dadamessi I, Dapvril V, Davion T, Dautreme S, Debas J, Degrave N, Dehont F, Delatre C, Delcenserie R, Delette O, Delgrange T, Delhoustal L, Delmotte JS, Demmane S, Deregnaucourt G, Descombes P, Desechalliers JP, Desmet P, Desreumaux P, Desseaux G, Desurmont P, Devienne A, Devouge E, Devred M, Devroux A, Dewailly A, Dharancy S, Di Fiore A, Djeddi D, Djedir R, Dreher-Duwat ML, Dubois R, Dubuque C, Ducatillon P, Duclay J, Ducrocq B, Ducrot F, Ducrotte P, Dufilho A, Duhamel C, Dujardin D, Dumant-Forest C, Dupas JL, Dupont F, Duranton Y, Duriez A, El Achkar K, El Farisi M, Elie C, Elie-Legrand MC, Elkhaki A, Eoche M, Evrard D, Evrard JP, Fatome A, Filoche B, Finet L, Flahaut M, Flamme C, Foissey D, Fournier P, Foutrein-Comes MC, Foutrein P, Fremond D, Frere T, Fumery M, Gallet P, Gamblin C, Ganga-Zandzou PS, Gerard R, Geslin G, Gheyssens Y, Ghossini N, Ghrib S, Gilbert T, Gillet B, Godard D, Godard P, Godchaux JM, Godchaux R, Goegebeur G, Goria O, Gottrand F, Gower P, Grandmaison B, Groux M, Guedon C, Guillard JF, Guillem L, Guillemot F, Guimber D, Haddouche B, Hakim S, Hanon D, Hautefeuille V, Heckestweiller P, Hecquet G, Hedde JP, Hellal H, Henneresse PE, Heyman B, Heraud M, Herve S, Hochain P, Houssin-Bailly L, Houcke P, Huguenin B, Iobagiu S, Ivanovic A, Iwanicki-Caron I, Janicki E, Jarry M, Jeu J, Joly JP, Jonas C, Katherin F, Kerleveo A, Khachfe A, Kiriakos A, Kiriakos J, Klein O, Kohut M, Kornhauser R, Koutsomanis D, Laberenne JE, Laffineur G, Lagarde M, Lannoy P, Lapchin J, Lapprand M, Laude D, Leblanc R, Lecieux P, Leclerc N, Le Couteulx C, Ledent J, Lefebvre J, Lefiliatre P, Legrand C, Le Grix A, Lelong P, Leluyer B, Lenaerts C, Lepileur L, Leplat A, Lepoutre-Dujardin E, Leroi H, Leroy MY, Lesage JP, Lesage X, Lesage J, Lescanne-Darchis I, Lescut J, Lescut D, Leurent B, Levy P, Lhermie M, Lion A, Lisambert B, Loire F, Louf S, Louvet A, Luciani M, Lucidarme D, Lugand J, Macaigne O, Maetz D, Maillard D, Mancheron H, Manolache O, Marks-Brunel AB, Marti R, Martin F, Martin G, Marzloff E, Mathurin P, Mauillon J, Maunoury V, Maupas JL, Mesnard B, Metayer P, Methari L, Meurisse B, Meurisse F, Michaud L, Mirmaran X, Modaine P, Monthe A, Morel L, Mortier PE, Moulin E, Mouterde O, Mudry J, Nachury M, Khac NE, Notteghem B, Ollevier V, Ostyn A, Ouraghi A, Ouvry D, Paillot B, Panien-Claudot N, Paoletti C, Papazian A, Parent B, Pariente B, Paris JC, Patrier P, Paupart L, Pauwels B, Pauwels M, Petit R, Piat M, Piotte S, Plane C, Plouvier B, Pollet E, Pommelet P, Pop D, Pordes C, Pouchain G, Prades P, Prevost A, Prevost JC, Quesnel B, Queuniet AM, Quinton JF, Rabache A, Rabelle P, Raclot G, Ratajczyk S, Rault D, Razemon V, Reix N, Revillon M, Richez C, Robinson P, Rodriguez J, Roger J, Roux JM, Rudelli A, Saber A, Savoye G, Schlosseberg P, Segrestin M, Seguy D, Serin M, Seryer A, Sevenet F, Shekh N, Silvie J, Simon V, Spyckerelle C, Talbodec N, Techy A, Thelu JL, Thevenin A, Thiebault H, Thomas J, Thorel JM, Tielman G, Tode M, Toisin J, Tonnel J, Touchais JY, Touze Y, Tranvouez JL, Triplet C, Turck D, Uhlen S, Vaillant E, Valmage C, Vanco D, Vandamme H, Vanderbecq E, Eecken VE, Vandermolen P, Vandevenne P, Vandeville L, Vandewalle A, Vandewalle C, Vaneslander P, Vanhoove JP, Vanrenterghem A, Varlet P, Vasies I, Verbiese G, Vernier-Massouille G, Vermelle P, Verne C, Vezilier-Cocq P, Vigneron B, Vincendet M, Viot J, Voiment YM, Wacrenier A, Waeghemaecker L, Wallez JY, Wantiez M, Wartel F, Weber J, Willocquet JL, Wizla N, Wolschies E, Zalar A, Zaouri B, Zellweger A, Ziade C; Epimad Group. Dramatic Increase in Incidence of Ulcerative Colitis and Crohn's Disease (1988-2011): A Population-Based Study of French Adolescents. Am J Gastroenterol. 2018 Feb;113(2):265-272. doi: 10.1038/ajg.2017.228. Epub 2017 Aug 15.
- Background: PubMed 28137597Rath T, Bojarski C, Neurath MF, Atreya R. Molecular imaging of mucosal alpha4beta7 integrin expression with the fluorescent anti-adhesion antibody vedolizumab in Crohn's disease. Gastrointest Endosc. 2017 Aug;86(2):406-408. doi: 10.1016/j.gie.2017.01.012. Epub 2017 Jan 27. No abstract available.
- Background: PubMed 36378498Iacucci M, Jeffery L, Acharjee A, Grisan E, Buda A, Nardone OM, Smith SCL, Labarile N, Zardo D, Ungar B, Hunter S, Mao R, Cannatelli R, Shivaji UN, Parigi TL, Reynolds GM, Gkoutos GV, Ghosh S. Computer-Aided Imaging Analysis of Probe-Based Confocal Laser Endomicroscopy With Molecular Labeling and Gene Expression Identifies Markers of Response to Biological Therapy in IBD Patients: The Endo-Omics Study. Inflamm Bowel Dis. 2023 Sep 1;29(9):1409-1420. doi: 10.1093/ibd/izac233.
- Background: PubMed 19107783Hyams JS, Lerer T, Griffiths A, Pfefferkorn M, Kugathasan S, Evans J, Otley A, Carvalho R, Mack D, Bousvaros A, Rosh J, Mamula P, Kay M, Crandall W, Oliva-Hemker M, Keljo D, LeLeiko N, Markowitz J; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Inflamm Bowel Dis. 2009 Jun;15(6):816-22. doi: 10.1002/ibd.20845.
- Background: PubMed 19174781Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.
- Background: PubMed 36279923Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.
- Background: PubMed 24691113Lim LG, Neumann J, Hansen T, Goetz M, Hoffman A, Neurath MF, Galle PR, Chan YH, Kiesslich R, Watson AJ. Confocal endomicroscopy identifies loss of local barrier function in the duodenum of patients with Crohn's disease and ulcerative colitis. Inflamm Bowel Dis. 2014 May;20(5):892-900. doi: 10.1097/MIB.0000000000000027.
- Background: PubMed 30849396Auzoux J, Boschetti G, Anon B, Aubourg A, Caulet M, Poisson L, Besson P, Lecomte T, Roger S, Picon L, Nancey S, Moussata D, Flourie B. Usefulness of confocal laser endomicroscopy for predicting postoperative recurrence in patients with Crohn's disease: a pilot study. Gastrointest Endosc. 2019 Jul;90(1):151-157. doi: 10.1016/j.gie.2019.02.030. Epub 2019 Mar 5.
- Background: PubMed 26583952Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Klausen P, Cartana T, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy: a novel method for prediction of relapse in Crohn's disease. Endoscopy. 2016 Apr;48(4):364-72. doi: 10.1055/s-0034-1393314. Epub 2015 Nov 19.
- Background: PubMed 22115910Kiesslich R, Duckworth CA, Moussata D, Gloeckner A, Lim LG, Goetz M, Pritchard DM, Galle PR, Neurath MF, Watson AJ. Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory bowel disease. Gut. 2012 Aug;61(8):1146-53. doi: 10.1136/gutjnl-2011-300695. Epub 2011 Nov 24.
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- 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.
Chief Research Officer contact
Clifton Huang, MD principal investigator
Cook Children's Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal Laser Endomicroscopy in people with IBD (Inflammatory Bowel Disease) and IBD, run by Cook Children's Health Care System at 2 sites in United States.
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 1 inclusion and 2 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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 FITC tagged antibodies (time frame: Baseline). 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 NCT07121920, which also lists 14 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 14 Aug 2025.