Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04286659
Other study ID # Polymorphisms in IBD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date December 2023

Study information

Verified date February 2020
Source Assiut University
Contact Noha R Abdelhamid
Phone 01007304366
Email noharefaat02@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The inflammatory bowel diseases (IBD) are chronic inflammatory disorders of the gastrointestinal tract that manifests as Crohn's disease (CD) and Ulcerative colitis (UC . Over the last two decades the incidence pattern of UC showed significant increase in previously low incidence areas such as Asia and the Middle East. In addition to microbial and environmental factors influencing IBDs, they are complex genetically, where hundreds of genetic loci contribute to disease susceptibility . Genome-wide association studies (GWAS) have identified several genetic susceptibility loci for UC and CD. Among the genetic factors involved, there are several single nucleotide polymorphisms (SNP) in molecules of the immune system associated with either susceptibility or protective effects to IBD progression, but with contradictory associations, mainly depending on the onset (adult or pediatric), sample size differences, inadequate statistical power and on the ethnicity-dependent genetic background. Growing evidence indicates that (RAGE) is involved in chronic inflammation and cancer. It is a transmembrane receptor normally expressed at low levels on a wide range of cells, bind a broad spectrum of ligands. Activated RAGE induces the synthesis of proinflammatory molecules resulting in magnifying rather than dampening inflammation . The human RAGE gene is located on chromosome 6p21.3, in the so-called class III of the major histocompatibility complex. The SNP at the -374A/T and -429T/C of the promoter region have been shown to increase protein synthesis threefold and twofold, respectively. Few studies found that RAGE is up-regulated in IBD, and it appears to play a role in the mechanisms involved in chronic inflammation Little information is available on the possible association of such polymorphisms with IBD. Few studies was carried out in different countries to assess these polymorphisms in IBD, resulting in conflicting results, between supporting and denial of the association. Due to this discrepancy we aimed to study this gene in our community including IBD patients.


Description:

This study aims:

1. To investigate the association of both allelic and genotypic -374T/A and -429T/C polymorphisms and inflammatory bowel disease.

2. To correlate the relation between the studied SNPs , disease activity and the clinical features of the disease.

Subjects and Methods:

This is a case control study. The study will include 90 patients diagnosed as IBD. Patients will be recruited from outpatient department of Elraghey Liver Hospital in Assiut University Hospital.The clinical disease activity was calculated using the Montreal classification of disease activity and Crohn's Disease Activity Index (CDAI) for UC and CD patients, respectively (Silverberg et al., 2005).

-Also, 90 apparently healthy subjects (age and sex matched with the patient group) will be included as control group.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date December 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Egyprian IBD patients Attending ElRaghy Hospital in Assuit University hopital

-

Exclusion Criteria:

- Exclusion criteria included the presence of neurological or cardiovascular diseases, diabetes, acute systemic illnesses, and previous or current history of cancer.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (10)

Ciccocioppo R, Bozzini S, Betti E, Imbesi V, Klersy C, Lakyova LS, Sukovsky L, Benacka J, Kruzliak P, Corazza GR, Di Sabatino A, Falcone C. Functional polymorphisms of the receptor for the advanced glycation end product promoter gene in inflammatory bowel disease: a case-control study. Clin Exp Med. 2019 Aug;19(3):367-375. doi: 10.1007/s10238-019-00562-x. Epub 2019 Jun 7. — View Citation

Girardelli M, Basaldella F, Paolera SD, Vuch J, Tommasini A, Martelossi S, Crovella S, Bianco AM. Genetic profile of patients with early onset inflammatory bowel disease. Gene. 2018 Mar 1;645:18-29. doi: 10.1016/j.gene.2017.12.029. Epub 2017 Dec 15. — View Citation

Hudson BI, Stickland MH, Futers TS, Grant PJ. Effects of novel polymorphisms in the RAGE gene on transcriptional regulation and their association with diabetic retinopathy. Diabetes. 2001 Jun;50(6):1505-11. — View Citation

Jostins L, Ripke S, Weersma RK, Duerr RH, McGovern DP, Hui KY, Lee JC, Schumm LP, Sharma Y, Anderson CA, Essers J, Mitrovic M, Ning K, Cleynen I, Theatre E, Spain SL, Raychaudhuri S, Goyette P, Wei Z, Abraham C, Achkar JP, Ahmad T, Amininejad L, Ananthakrishnan AN, Andersen V, Andrews JM, Baidoo L, Balschun T, Bampton PA, Bitton A, Boucher G, Brand S, Büning C, Cohain A, Cichon S, D'Amato M, De Jong D, Devaney KL, Dubinsky M, Edwards C, Ellinghaus D, Ferguson LR, Franchimont D, Fransen K, Gearry R, Georges M, Gieger C, Glas J, Haritunians T, Hart A, Hawkey C, Hedl M, Hu X, Karlsen TH, Kupcinskas L, Kugathasan S, Latiano A, Laukens D, Lawrance IC, Lees CW, Louis E, Mahy G, Mansfield J, Morgan AR, Mowat C, Newman W, Palmieri O, Ponsioen CY, Potocnik U, Prescott NJ, Regueiro M, Rotter JI, Russell RK, Sanderson JD, Sans M, Satsangi J, Schreiber S, Simms LA, Sventoraityte J, Targan SR, Taylor KD, Tremelling M, Verspaget HW, De Vos M, Wijmenga C, Wilson DC, Winkelmann J, Xavier RJ, Zeissig S, Zhang B, Zhang CK, Zhao H; International IBD Genetics Consortium (IIBDGC), Silverberg MS, Annese V, Hakonarson H, Brant SR, Radford-Smith G, Mathew CG, Rioux JD, Schadt EE, Daly MJ, Franke A, Parkes M, Vermeire S, Barrett JC, Cho JH. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature. 2012 Nov 1;491(7422):119-24. doi: 10.1038/nature11582. — View Citation

Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2018 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16. Review. — View Citation

Norouzinia M, Naderi N. Personalized management of IBD; is there any practical approach? Gastroenterol Hepatol Bed Bench. 2015 Winter;8(1):1-3. — View Citation

Schmidt AM, Yan SD, Yan SF, Stern DM. The multiligand receptor RAGE as a progression factor amplifying immune and inflammatory responses. J Clin Invest. 2001 Oct;108(7):949-55. Review. — View Citation

Sims GP, Rowe DC, Rietdijk ST, Herbst R, Coyle AJ. HMGB1 and RAGE in inflammation and cancer. Annu Rev Immunol. 2010;28:367-88. doi: 10.1146/annurev.immunol.021908.132603. Review. — View Citation

Sugaya K, Fukagawa T, Matsumoto K, Mita K, Takahashi E, Ando A, Inoko H, Ikemura T. Three genes in the human MHC class III region near the junction with the class II: gene for receptor of advanced glycosylation end products, PBX2 homeobox gene and a notch homolog, human counterpart of mouse mammary tumor gene int-3. Genomics. 1994 Sep 15;23(2):408-19. — View Citation

Zallot C, Peyrin-Biroulet L. Deep remission in inflammatory bowel disease: looking beyond symptoms. Curr Gastroenterol Rep. 2013 Mar;15(3):315. doi: 10.1007/s11894-013-0315-7. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Association Of gene polymorphisms -374T/A and -429T/C in IBD patients Compare the percentage of the polymorphism in Controls vs Patients 2020- 2023
Secondary To correlate the relation between the studied SNPs , disease activity and the clinical features of the disease find If there is a relation between the Found SNPs and disease activity and feature 2020-2023
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02874365 - Intestinal Stem Cells Characterization N/A