Diagnosis of Inflammatory Bowel Disease

NCT07400211 | Not Yet Recruiting

• 1 other identifier: Non-invasive diagnosis of IBD
• Study Type: observational
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

• To quantify the expression of Nuclear enriched abundant transcript 1 (NEAT1) and Anti-sense Non RNA in the INLK4 locus (ANRIL) to determine their potential role as non invasive diagnostic biomarkers in inflammatory bowel disease.
• To evaluate the correlation between the studied biomarkers and both the clinical presentation of the patients and the inflammatory mediators like Nuclear factor κB (NF-KB) signaling pathway.

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• To quantify the expression of NEAT1 and ANRIL to determine their potential role as non invasive diagnostic biomarkers in inflammatory bowel disease.

  Measure level of NEAT1 and ANRIL genes in blood samples of inflammatory bowel disease patients

  Baseline

Secondary Outcomes (1)

• To evaluate the correlation between the studied biomarkers among the studied groups explored and both their clinical presentations and the inflammatory mediators like NF-KB signaling pathway.

  Baseline

Study Arms (2)

Patients with inflammatory bowel disease

Healthy normal persons

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease

You may qualify if:

• Newly histopathologicaly diagnosed IBD

You may not qualify if:

• Patients with serious complications as intestinal obstruction, perforation, polyps or colorectal carcinoma
• Patients who are taking NSAIDs or Immunosuppressive drugs
• Patients who are having other autoimmune disorders
• Patients with Chronic infections as TB or other diseases
• Patients with a history of allergy
• Pregnant or Lactating women

Sponsors & Collaborators

• Assiut University: lead

Related Publications (16)

• Laurindo LF, Santos AROD, Carvalho ACA, Bechara MD, Guiguer EL, Goulart RA, Vargas Sinatora R, Araujo AC, Barbalho SM. Phytochemicals and Regulation of NF-kB in Inflammatory Bowel Diseases: An Overview of In Vitro and In Vivo Effects. Metabolites. 2023 Jan 7;13(1):96. doi: 10.3390/metabo13010096.

  PMID: 36677021 BACKGROUND

• Pan Y, Wang T, Zhao Z, Wei W, Yang X, Wang X, Xin W. Novel Insights into the Emerging Role of Neat1 and Its Effects Downstream in the Regulation of Inflammation. J Inflamm Res. 2022 Jan 26;15:557-571. doi: 10.2147/JIR.S338162. eCollection 2022.

  PMID: 35115805 BACKGROUND

• Walther K, Schulte LN. The role of lncRNAs in innate immunity and inflammation. RNA Biol. 2021 May;18(5):587-603. doi: 10.1080/15476286.2020.1845505. Epub 2020 Nov 19.

  PMID: 33138685 BACKGROUND

• Mineo M, Lyons SM, Zdioruk M, von Spreckelsen N, Ferrer-Luna R, Ito H, Alayo QA, Kharel P, Giantini Larsen A, Fan WY, Auduong S, Grauwet K, Passaro C, Khalsa JK, Shah K, Reardon DA, Ligon KL, Beroukhim R, Nakashima H, Ivanov P, Anderson PJ, Lawler SE, Chiocca EA. Tumor Interferon Signaling Is Regulated by a lncRNA INCR1 Transcribed from the PD-L1 Locus. Mol Cell. 2020 Jun 18;78(6):1207-1223.e8. doi: 10.1016/j.molcel.2020.05.015. Epub 2020 Jun 5.

  PMID: 32504554 BACKGROUND

• Leitao AL, Enguita FJ. A Structural View of miRNA Biogenesis and Function. Noncoding RNA. 2022 Jan 18;8(1):10. doi: 10.3390/ncrna8010010.

  PMID: 35202084 BACKGROUND

• Johnson JL, Sargsyan D, Neiman EM, Hart A, Stojmirovic A, Kosoy R, Irizar H, Suarez-Farinas M, Song WM, Argmann C, Avey S, Shmuel-Galia L, Vierbuchen T, Bongers G, Sun Y, Edelstein L, Perrigoue J, Towne JE, Hall AO, Fitzgerald KA, Hoebe K. Gene coexpression networks reveal a broad role for lncRNAs in inflammatory bowel disease. JCI Insight. 2024 Feb 8;9(3):e168988. doi: 10.1172/jci.insight.168988.

  PMID: 38329124 BACKGROUND

• Hossam Abdelmonem B, Kamal LT, Wardy LW, Ragheb M, Hanna MM, Elsharkawy M, Abdelnaser A. Non-coding RNAs: emerging biomarkers and therapeutic targets in cancer and inflammatory diseases. Front Oncol. 2025 Mar 10;15:1534862. doi: 10.3389/fonc.2025.1534862. eCollection 2025.

  PMID: 40129920 BACKGROUND

• Luo Q, Wang J, Ge W, Li Z, Mao Y, Wang C, Zhang L. Exploration of the potential causative genes for inflammatory bowel disease: Transcriptome-wide association analysis, Mendelian randomization analysis and Bayesian colocalisation. Heliyon. 2024 Apr 6;10(7):e28944. doi: 10.1016/j.heliyon.2024.e28944. eCollection 2024 Apr 15.

  PMID: 38617957 BACKGROUND

• Sato Y, Tsujinaka S, Miura T, Kitamura Y, Suzuki H, Shibata C. Inflammatory Bowel Disease and Colorectal Cancer: Epidemiology, Etiology, Surveillance, and Management. Cancers (Basel). 2023 Aug 17;15(16):4154. doi: 10.3390/cancers15164154.

  PMID: 37627182 BACKGROUND

• Li T, Jing H, Gao X, Zhang T, Yao H, Zhang X, Zhang M. Identification of key genes as diagnostic biomarkers for IBD using bioinformatics and machine learning. J Transl Med. 2025 Jul 3;23(1):738. doi: 10.1186/s12967-025-06531-1.

  PMID: 40611294 BACKGROUND

• Erfan R, Shaker OG, Khalil MAF, Mahmoud FAM, Gomaa MS, Abu-El-Azayem AK, Zaki OM, Ahmed AM, Samy A, Mohammed A. Circulating miR-199a and long noncoding-RNA ANRIL as Promising Diagnostic Biomarkers for Inflammatory Bowel Disease. Inflamm Bowel Dis. 2024 Sep 3;30(9):1500-1509. doi: 10.1093/ibd/izad210.

  PMID: 38190238 BACKGROUND

• Lin D, Jin Y, Shao X, Xu Y, Ma G, Jiang Y, Xu Y, Jiang Y, Hu D. Global, regional, and national burden of inflammatory bowel disease, 1990-2021: Insights from the global burden of disease 2021. Int J Colorectal Dis. 2024 Sep 7;39(1):139. doi: 10.1007/s00384-024-04711-x.

  PMID: 39243331 BACKGROUND

• AlMuhaidib S, Bzeizi K, AlAmeel T, Mosli M, Khoja B, Barakeh D, Alomaim WS, Alqahtani SA, Al-Bawardy B. A bibliometric analysis of inflammatory bowel disease research in the Arab world. Saudi J Gastroenterol. 2025 May 1;31(3):146-156. doi: 10.4103/sjg.sjg_303_24. Epub 2024 Dec 11.

  PMID: 39660608 BACKGROUND

• Heydari K, Rahnavard M, Ghahramani S, Hoseini A, Alizadeh-Navaei R, Rafati S, Raei M, Vahidipour M, Salehi F, Motafeghi F, Neshat S, Moosazadeh M, Yousefi M, Pourali A, Rasouli K, Shokrirad S, Lotfi P, Beladi SA, Hadizadeh Neisanghalb M, Sheydaee F, Moghadam S. Global prevalence and incidence of inflammatory bowel disease: a systematic review and meta-analysis of population-based studies. Gastroenterol Hepatol Bed Bench. 2025;18(2):132-146. doi: 10.22037/ghfbb.v18i2.3105.

  PMID: 40936779 BACKGROUND

• Hu Y, Lu Y, Fang Y, Zhang Q, Zheng Z, Zheng X, Ye X, Chen Y, Ding J, Yang J. Role of long non-coding RNA in inflammatory bowel disease. Front Immunol. 2024 Jun 4;15:1406538. doi: 10.3389/fimmu.2024.1406538. eCollection 2024.

  PMID: 38895124 BACKGROUND

• Mak WY, Zhao M, Ng SC, Burisch J. The epidemiology of inflammatory bowel disease: East meets west. J Gastroenterol Hepatol. 2020 Mar;35(3):380-389. doi: 10.1111/jgh.14872. Epub 2019 Nov 24.

  PMID: 31596960 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Sandy Sameh Naguib

CONTACT

+201224430410; sandysameh@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02