Irritable Bowel Syndrome (IBS)NCT07051226
Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome (IBS), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.).
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
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)
Read the detailed description
The study is prospective, observational, and diagnostic.
Research methodology Equipment Consumables The equipment consumables used include a colonoscopy operating system, pCLE system, fluorescein sodium injection, and single-use endoscopic biopsy forceps.
Phase 1 Endoscopy All enrolled person receive fluorescein sodium allergy test before pCLE examination, and fluorescein sodium is injected intravenously after observing no allergic reactions such as dizziness, rash, itching, shock, etc. for 15 min. 30 s later, the pCLE probe is placed from the biopsy clamp channel of enteroscopy, and six different intestinal segments of the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum are examined in order and the images are collected, and each intestinal segment of the pCLE of all person is recorded continuously with 3-minute video recordings (operation is kept within 30 min after the procedure). and more than 4000 images are recorded for each person. During the operation, the probe is gently placed on the mucosal surface and kept as perpendicular to the bowel wall as possible, and the movements are gentle, slow, and soft to avoid mucosal injury. The endoscopist is performing targeted biopsies of all suspicious lesions and lesion margins observed in pCLE.
Pathological analysis After the specimens are fixed in formalin solution and embedded in paraffin, 2 sections with a thickness of 4 μm are cut. The first section is stained with HE to evaluate the mild inflammation of the intestine; the second section is stained with immunohistochemistry to evaluate the mast cell markers and tight junction proteins in the intestinal wall.
Screening of characteristic pCLE images All videos are measured and analyzed by the same experienced endoscopist, after screening all images with good stability, no artifacts, and clear display of microstructures. pCLE images are characterized by a ruler of 10 μm in length in the lower left corner, which allows real-time evaluation of a number of parameters in real time during the operation. Image J image analysis software is used to measure capillary diameter (CD), cell spacing (CS), gland spacing (GS), gland area (GA), and whether sodium fluorescein leak into the crypt lumen in the pCLE field of view. and other indicators. The images are categorized according to the healthy control group and the IBS patient group, and the characteristic images of each group are formed.
Phase 2 Diagnostic model construction of IBS patient images Deep learning is performed based on two sets of characteristic images to construct a diagnostic model for IBS.
Model evaluation Patients with healthy, IBS, early IBD, or celiac disease (total sample size of 30 cases for total diagnostic model efficacy validation in phases 2 and 3) are examined for pCLE in the same way as in phase 1, and high-quality images are screened for discriminative diagnosis of this model and evaluated for accuracy and inter-evaluator agreement of their diagnostic findings.
Phase 3 Construction of a multimodal diagnostic model for images of IBS patients with joint text On the basis of phase 2, the text data of various indicators corresponding to the images are added for joint deep learning to construct a multimodal diagnostic model for IBS patients.
Model evaluation Patients with healthy, IBS, early IBD, or celiac disease (total sample size of 30 cases for validation of diagnostic model efficacy in phases 2 and 3 combined) are examined for pCLE in the same way as in phase 1, with high-quality images and various types of indicators screened for discriminatory diagnosis of this model and evaluated for the accuracy of the diagnostic results and inter-appraisal agreement.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Not described | |
| IBS test group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 15 months from completion of image collection, analysis, deep learning and construction of IBS diagnostic model to validation of diagnostic model performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaijun Liu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051226
- Sponsor's protocol ID
- Ratification NO:2025(203)
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31100380Fritscher-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 25083606Bertiaux-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.
PubMed 22008894Liu 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.
PubMed 23237881Robles-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.
PubMed 32258379Kiesslich 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.
PubMed 18054549Liu 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.
PubMed 21396639ASGE Technology Committee. Confocal laser endomicroscopy. Gastrointest Endosc. 2014 Dec;80(6):928-38. doi: 10.1016/j.gie.2014.06.021. No abstract available.
PubMed 25442092Piche 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.
PubMed 18824556Martinez 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.
PubMed 22637702Hughes 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.
PubMed 22767422Liu 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.
PubMed 27266978Martinez 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.
PubMed 22844557Montrose 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.
PubMed 12631555Clayburgh 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.
PubMed 14767487
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07051226
- Acronym / sponsor ID
- Ratification NO:2025(203)
- Conditions
- Irritable Bowel Syndrome (IBS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jul 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.
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)
Detailed description
The study is prospective, observational, and diagnostic.
Research methodology Equipment Consumables The equipment consumables used include a colonoscopy operating system, pCLE system, fluorescein sodium injection, and single-use endoscopic biopsy forceps.
Phase 1 Endoscopy All enrolled person receive fluorescein sodium allergy test before pCLE examination, and fluorescein sodium is injected intravenously after observing no allergic reactions such as dizziness, rash, itching, shock, etc. for 15 min. 30 s later, the pCLE probe is placed from the biopsy clamp channel of enteroscopy, and six different intestinal segments of the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum are examined in order and the images are collected, and each intestinal segment of the pCLE of all person is recorded continuously with 3-minute video recordings (operation is kept within 30 min after the procedure). and more than 4000 images are recorded for each person. During the operation, the probe is gently placed on the mucosal surface and kept as perpendicular to the bowel wall as possible, and the movements are gentle, slow, and soft to avoid mucosal injury. The endoscopist is performing targeted biopsies of all suspicious lesions and lesion margins observed in pCLE.
Pathological analysis After the specimens are fixed in formalin solution and embedded in paraffin, 2 sections with a thickness of 4 μm are cut. The first section is stained with HE to evaluate the mild inflammation of the intestine; the second section is stained with immunohistochemistry to evaluate the mast cell markers and tight junction proteins in the intestinal wall.
Screening of characteristic pCLE images All videos are measured and analyzed by the same experienced endoscopist, after screening all images with good stability, no artifacts, and clear display of microstructures. pCLE images are characterized by a ruler of 10 μm in length in the lower left corner, which allows real-time evaluation of a number of parameters in real time during the operation. Image J image analysis software is used to measure capillary diameter (CD), cell spacing (CS), gland spacing (GS), gland area (GA), and whether sodium fluorescein leak into the crypt lumen in the pCLE field of view. and other indicators. The images are categorized according to the healthy control group and the IBS patient group, and the characteristic images of each group are formed.
Phase 2 Diagnostic model construction of IBS patient images Deep learning is performed based on two sets of characteristic images to construct a diagnostic model for IBS.
Model evaluation Patients with healthy, IBS, early IBD, or celiac disease (total sample size of 30 cases for total diagnostic model efficacy validation in phases 2 and 3) are examined for pCLE in the same way as in phase 1, and high-quality images are screened for discriminative diagnosis of this model and evaluated for accuracy and inter-evaluator agreement of their diagnostic findings.
Phase 3 Construction of a multimodal diagnostic model for images of IBS patients with joint text On the basis of phase 2, the text data of various indicators corresponding to the images are added for joint deep learning to construct a multimodal diagnostic model for IBS patients.
Model evaluation Patients with healthy, IBS, early IBD, or celiac disease (total sample size of 30 cases for validation of diagnostic model efficacy in phases 2 and 3 combined) are examined for pCLE in the same way as in phase 1, with high-quality images and various types of indicators screened for discriminatory diagnosis of this model and evaluated for the accuracy of the diagnostic results and inter-appraisal agreement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | – |
| IBS test group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the accuracy and inter-evaluator agreement of the constructed IBS diagnostic model with the diagnostic results of the Rome IV criteria.
Time frame: Approximately 15 months from completion of image collection, analysis, deep learning and construction of IBS diagnostic model to validation of diagnostic model performance.
Diagnostic model constructed from CLE-based image data and multimodal model constructed from fused image joint text data
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 4 Jul 2025.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 22008894Bertiaux-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.
- Results publication: PubMed 23237881Liu 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.
- Results publication: PubMed 32258379Robles-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.
- Results publication: PubMed 18054549Kiesslich 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.
- Results publication: PubMed 21396639Liu 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.
- Results publication: PubMed 25442092ASGE Technology Committee. Confocal laser endomicroscopy. Gastrointest Endosc. 2014 Dec;80(6):928-38. doi: 10.1016/j.gie.2014.06.021. No abstract available.
- Results publication: PubMed 18824556Piche 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.
- Results publication: PubMed 22637702Martinez 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.
- Results publication: PubMed 22767422Hughes 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.
- Results publication: PubMed 27266978Liu 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome (IBS), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 1 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 4 Jul 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 Yuanyuan Ai (86-18171802961, 316273225@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the accuracy and inter-evaluator agreement of the constructed IBS diagnostic model with the diagnostic results of the Rome IV criteria. (time frame: Approximately 15 months from completion of image collection, analysis, deep learning and construction of IBS diagnostic model to validation of diagnostic model performance.). 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 NCT07051226, which also lists 32 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 4 Jul 2025.