Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome

NCT07051226 | Not Yet Recruiting

• 1 other identifier: Ratification NO:2025(203)
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the healthy control group and IBS patients are taken as the research subjects, and CLE is applied to image and analyze the enrolled persons respectively, to derive and compare the characteristic microstructural images of the healthy control group with those of the IBS patients, to establish a diagnostic model of IBS by using deep learning and to evaluate the diagnostic efficacy of the model for IBS.Participants will undergo colonoscopy and confocal laser microendoscopy, and IBS patients will undergo targeted biopsy in CLE to observe suspicious lesions and lesion margins, and specimens will undergo HE staining and immunohistochemistry testing. Translated with DeepL.com (free version)

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

• Evaluation of the accuracy and inter-evaluator agreement of the constructed IBS diagnostic model with the diagnostic results of the Rome IV criteria.

  Diagnostic model constructed from CLE-based image data and multimodal model constructed from fused image joint text data

  Approximately 15 months from completion of image collection, analysis, deep learning and construction of IBS diagnostic model to validation of diagnostic model performance.

Study Arms (2)

Healthy control group

IBS test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.Between the ages of 18 and 80 years old.

You may qualify if:

• ①Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.② Age: between 18 and 80 years old.③ Probe-based confocal Laser Endomicroscopy (pCLE) is required, and patients have good compliance. ④ Normal coagulation function, and biopsies can be obtained for pathological examination.⑤ Voluntary signing of informed consent.

You may not qualify if:

• Fluorescein sodium allergy. ②Contraindications to colonoscopy (pregnant or breastfeeding patients, uncooperative psychiatric patients with severe mental disorders, colonic obstruction) or inadequate bowel preparation (Boston Bowel Preparedness Scale score of \<2 for any colonic segment).③ Comorbidities with major organ dysfunction (with severe cardiopulmonary disease) or impaired renal function (blood creatinine \>450umol/L). ④ Other conditions that, in the judgment of the investigator, make it unsuitable for participation in the study (inflammatory bowel disease, infected IBS, having taken nonsteroidal anti inflammatory drugs, corticosteroids or antibiotics within the last year, etc.).

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Related Publications (32)

• Fritscher-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.

  PMID: 31100380 BACKGROUND

• Fritscher-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.

  PMID: 25083606 BACKGROUND

• Bertiaux-Vandaele N, Youmba SB, Belmonte L, Lecleire S, Antonietti M, Gourcerol G, Leroi AM, Dechelotte P, Menard JF, Ducrotte P, Coeffier M. The expression and the cellular distribution of the tight junction proteins are altered in irritable bowel syndrome patients with differences according to the disease subtype. Am J Gastroenterol. 2011 Dec;106(12):2165-73. doi: 10.1038/ajg.2011.257. Epub 2011 Oct 18.

  PMID: 22008894 BACKGROUND

• Liu JJ, Rudzinski JK, Mah SJ, Thiesen AL, Bao H, Wine E, Ogg SC, Boulanger P, Fedorak RN, Madsen KL. Epithelial gaps in a rodent model of inflammatory bowel disease: a quantitative validation study. Clin Transl Gastroenterol. 2011 Jun 9;2(6):e3. doi: 10.1038/ctg.2011.2.

  PMID: 23237881 BACKGROUND

• Robles-Medranda C, Oleas R, Valero M, Puga-Tejada M, Soria-Alcivar M, Ospina J, Alvarado-Escobar H, Munoz-Jurado G, Baquerizo-Burgos J, Pitanga-Lukashok H. Confocal laser endomicroscopy detects colonic inflammation in patients with irritable bowel syndrome: a prospective study. Endosc Int Open. 2020 Apr;8(4):E550-E557. doi: 10.1055/a-1119-6327. Epub 2020 Mar 23.

  PMID: 32258379 BACKGROUND

• Kiesslich R, Goetz M, Angus EM, Hu Q, Guan Y, Potten C, Allen T, Neurath MF, Shroyer NF, Montrose MH, Watson AJ. Identification of epithelial gaps in human small and large intestine by confocal endomicroscopy. Gastroenterology. 2007 Dec;133(6):1769-78. doi: 10.1053/j.gastro.2007.09.011. Epub 2007 Sep 16.

  PMID: 18054549 BACKGROUND

• Liu JJ, Wong K, Thiesen AL, Mah SJ, Dieleman LA, Claggett B, Saltzman JR, Fedorak RN. Increased epithelial gaps in the small intestines of patients with inflammatory bowel disease: density matters. Gastrointest Endosc. 2011 Jun;73(6):1174-80. doi: 10.1016/j.gie.2011.01.018. Epub 2011 Mar 11.

  PMID: 21396639 BACKGROUND

• ASGE Technology Committee. Confocal laser endomicroscopy. Gastrointest Endosc. 2014 Dec;80(6):928-38. doi: 10.1016/j.gie.2014.06.021. No abstract available.

  PMID: 25442092 BACKGROUND

• Piche T, Barbara G, Aubert P, Bruley des Varannes S, Dainese R, Nano JL, Cremon C, Stanghellini V, De Giorgio R, Galmiche JP, Neunlist M. Impaired intestinal barrier integrity in the colon of patients with irritable bowel syndrome: involvement of soluble mediators. Gut. 2009 Feb;58(2):196-201. doi: 10.1136/gut.2007.140806. Epub 2008 Sep 29.

  PMID: 18824556 BACKGROUND

• Martinez C, Lobo B, Pigrau M, Ramos L, Gonzalez-Castro AM, Alonso C, Guilarte M, Guila M, de Torres I, Azpiroz F, Santos J, Vicario M. Diarrhoea-predominant irritable bowel syndrome: an organic disorder with structural abnormalities in the jejunal epithelial barrier. Gut. 2013 Aug;62(8):1160-8. doi: 10.1136/gutjnl-2012-302093. Epub 2012 May 25.

  PMID: 22637702 BACKGROUND

• Hughes PA, Harrington AM, Castro J, Liebregts T, Adam B, Grasby DJ, Isaacs NJ, Maldeniya L, Martin CM, Persson J, Andrews JM, Holtmann G, Blackshaw LA, Brierley SM. Sensory neuro-immune interactions differ between irritable bowel syndrome subtypes. Gut. 2013 Oct;62(10):1456-65. doi: 10.1136/gutjnl-2011-301856. Epub 2012 Jul 5.

  PMID: 22767422 BACKGROUND

• Liu Y, Zhang L, Wang X, Wang Z, Zhang J, Jiang R, Wang X, Wang K, Liu Z, Xia Z, Xu Z, Nie Y, Lv X, Wu X, Zhu H, Duan L. Similar Fecal Microbiota Signatures in Patients With Diarrhea-Predominant Irritable Bowel Syndrome and Patients With Depression. Clin Gastroenterol Hepatol. 2016 Nov;14(11):1602-1611.e5. doi: 10.1016/j.cgh.2016.05.033. Epub 2016 Jun 4.

  PMID: 27266978 BACKGROUND

• Martinez C, Gonzalez-Castro A, Vicario M, Santos J. Cellular and molecular basis of intestinal barrier dysfunction in the irritable bowel syndrome. Gut Liver. 2012 Jul;6(3):305-15. doi: 10.5009/gnl.2012.6.3.305. Epub 2012 Jul 12.

  PMID: 22844557 BACKGROUND

• Montrose MH. The future of GI and liver research: editorial perspectives: I. Visions of epithelial research. Am J Physiol Gastrointest Liver Physiol. 2003 Apr;284(4):G547-50. doi: 10.1152/ajpgi.00547.2002.

  PMID: 12631555 BACKGROUND

• Clayburgh DR, Shen L, Turner JR. A porous defense: the leaky epithelial barrier in intestinal disease. Lab Invest. 2004 Mar;84(3):282-91. doi: 10.1038/labinvest.3700050.

  PMID: 14767487 BACKGROUND

• Turcotte 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.

  PMID: 23357497 BACKGROUND

• Choghakhori R, Abbasnezhad A, Hasanvand A, Amani R. Inflammatory cytokines and oxidative stress biomarkers in irritable bowel syndrome: Association with digestive symptoms and quality of life. Cytokine. 2017 May;93:34-43. doi: 10.1016/j.cyto.2017.05.005. Epub 2017 May 12.

  PMID: 28506572 BACKGROUND

• Bashashati M, Moossavi S, Cremon C, Barbaro MR, Moraveji S, Talmon G, Rezaei N, Hughes PA, Bian ZX, Choi CH, Lee OY, Coeffier M, Chang L, Ohman L, Schmulson MJ, McCallum RW, Simren M, Sharkey KA, Barbara G. Colonic immune cells in irritable bowel syndrome: A systematic review and meta-analysis. Neurogastroenterol Motil. 2018 Jan;30(1). doi: 10.1111/nmo.13192. Epub 2017 Aug 29.

  PMID: 28851005 BACKGROUND

• Spiegel BM, Farid M, Esrailian E, Talley J, Chang L. Is irritable bowel syndrome a diagnosis of exclusion?: a survey of primary care providers, gastroenterologists, and IBS experts. Am J Gastroenterol. 2010 Apr;105(4):848-58. doi: 10.1038/ajg.2010.47. Epub 2010 Mar 2.

  PMID: 20197761 BACKGROUND

• Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26.

  PMID: 23357491 BACKGROUND

• Camilleri M, Halawi H, Oduyebo I. Biomarkers as a diagnostic tool for irritable bowel syndrome: where are we? Expert Rev Gastroenterol Hepatol. 2017 Apr;11(4):303-316. doi: 10.1080/17474124.2017.1288096. Epub 2017 Feb 13.

  PMID: 28128666 BACKGROUND

• Nakov R, Snegarova V, Dimitrova-Yurukova D, Velikova T. Biomarkers in Irritable Bowel Syndrome: Biological Rationale and Diagnostic Value. Dig Dis. 2022;40(1):23-32. doi: 10.1159/000516027. Epub 2021 Mar 22.

  PMID: 33752201 BACKGROUND

• Ford AC, Lacy BE, Talley NJ. Irritable Bowel Syndrome. N Engl J Med. 2017 Jun 29;376(26):2566-2578. doi: 10.1056/NEJMra1607547. No abstract available.

  PMID: 28657875 BACKGROUND

• Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014 Jun 14;20(22):6759-73. doi: 10.3748/wjg.v20.i22.6759.

  PMID: 24944467 BACKGROUND

• Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954.

  PMID: 25734736 BACKGROUND

• Buono JL, Mathur K, Averitt AJ, Andrae DA. Economic burden of inadequate symptom control among US commercially insured patients with irritable bowel syndrome with diarrhea. J Med Econ. 2017 Apr;20(4):353-362. doi: 10.1080/13696998.2016.1269016. Epub 2017 Jan 4.

  PMID: 27919177 BACKGROUND

• Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.

  PMID: 27144627 BACKGROUND

• Choi MG, Jung HK. Health related quality of life in functional gastrointestinal disorders in Asia. J Neurogastroenterol Motil. 2011 Jul;17(3):245-51. doi: 10.5056/jnm.2011.17.3.245. Epub 2011 Jul 13.

  PMID: 21860816 BACKGROUND

• Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.

  PMID: 27147121 BACKGROUND

• Sood R, Law GR, Ford AC. Diagnosis of IBS: symptoms, symptom-based criteria, biomarkers or 'psychomarkers'? Nat Rev Gastroenterol Hepatol. 2014 Nov;11(11):683-91. doi: 10.1038/nrgastro.2014.127. Epub 2014 Jul 29.

  PMID: 25069544 BACKGROUND

• Camilleri M. Diagnosis and Treatment of Irritable Bowel Syndrome: A Review. JAMA. 2021 Mar 2;325(9):865-877. doi: 10.1001/jama.2020.22532.

  PMID: 33651094 BACKGROUND

• Ford AC, Sperber AD, Corsetti M, Camilleri M. Irritable bowel syndrome. Lancet. 2020 Nov 21;396(10263):1675-1688. doi: 10.1016/S0140-6736(20)31548-8. Epub 2020 Oct 10.

  PMID: 33049223 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue sections

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Yuanyuan Ai

CONTACT

86-18171802961; 316273225@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D,Associate Professor, Associate Chief Physician

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-06