NCT05598346

Brief Summary

To examine the level and function of MAIT cells in IBD patients, and to compare it with disease activity.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

October 25, 2022

Last Update Submit

November 9, 2022

Conditions

Keywords

Mucosal Associated Invariant T Cells

Outcome Measures

Primary Outcomes (1)

  • Detection of MAIT cells level in IBD,Compare its level with disease activity

    Monoclonal Antibodies by flow cytometry used for detection of MAIT cells in IBD patients

    Baseline

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Group of patients with active IBD according to clinical scores aged (15-50) , Another group of healthy controls.

You may qualify if:

  • Patients with active IBD according to clinical scores with the following:
  • Recently discovered.
  • Average age (15-50).

You may not qualify if:

  • Patient with history of any of the following ;
  • History of respiratory disorders such as chronic obstructive diseases, pulmonary disease or pulmonary embolism.
  • Other Autoimmune diseases, infectious diseases.
  • Recent surgery, malignancies, left ventricular dysfunction, use of immunosuppressive drugs.
  • Chronic liver, renal, and endocrine diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (26)

  • Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.

  • Garrett WS, Gordon JI, Glimcher LH. Homeostasis and inflammation in the intestine. Cell. 2010 Mar 19;140(6):859-70. doi: 10.1016/j.cell.2010.01.023.

  • Fonseca-Camarillo G, Yamamoto-Furusho JK. Immunoregulatory Pathways Involved in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2015 Sep;21(9):2188-93. doi: 10.1097/MIB.0000000000000477.

  • Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.

  • Giuffrida P, Corazza GR, Di Sabatino A. Old and New Lymphocyte Players in Inflammatory Bowel Disease. Dig Dis Sci. 2018 Feb;63(2):277-288. doi: 10.1007/s10620-017-4892-4. Epub 2017 Dec 23.

  • Geremia A, Biancheri P, Allan P, Corazza GR, Di Sabatino A. Innate and adaptive immunity in inflammatory bowel disease. Autoimmun Rev. 2014 Jan;13(1):3-10. doi: 10.1016/j.autrev.2013.06.004. Epub 2013 Jun 15.

  • Treiner E, Duban L, Bahram S, Radosavljevic M, Wanner V, Tilloy F, Affaticati P, Gilfillan S, Lantz O. Selection of evolutionarily conserved mucosal-associated invariant T cells by MR1. Nature. 2003 Mar 13;422(6928):164-9. doi: 10.1038/nature01433.

  • Kjer-Nielsen L, Patel O, Corbett AJ, Le Nours J, Meehan B, Liu L, Bhati M, Chen Z, Kostenko L, Reantragoon R, Williamson NA, Purcell AW, Dudek NL, McConville MJ, O'Hair RA, Khairallah GN, Godfrey DI, Fairlie DP, Rossjohn J, McCluskey J. MR1 presents microbial vitamin B metabolites to MAIT cells. Nature. 2012 Nov 29;491(7426):717-23. doi: 10.1038/nature11605. Epub 2012 Oct 10.

  • Napier RJ, Adams EJ, Gold MC, Lewinsohn DM. The Role of Mucosal Associated Invariant T Cells in Antimicrobial Immunity. Front Immunol. 2015 Jul 6;6:344. doi: 10.3389/fimmu.2015.00344. eCollection 2015.

  • Le Bourhis L, Martin E, Peguillet I, Guihot A, Froux N, Core M, Levy E, Dusseaux M, Meyssonnier V, Premel V, Ngo C, Riteau B, Duban L, Robert D, Huang S, Rottman M, Soudais C, Lantz O. Antimicrobial activity of mucosal-associated invariant T cells. Nat Immunol. 2010 Aug;11(8):701-8. doi: 10.1038/ni.1890. Epub 2010 Jun 27.

  • Dusseaux M, Martin E, Serriari N, Peguillet I, Premel V, Louis D, Milder M, Le Bourhis L, Soudais C, Treiner E, Lantz O. Human MAIT cells are xenobiotic-resistant, tissue-targeted, CD161hi IL-17-secreting T cells. Blood. 2011 Jan 27;117(4):1250-9. doi: 10.1182/blood-2010-08-303339. Epub 2010 Nov 17.

  • Cosgrove C, Ussher JE, Rauch A, Gartner K, Kurioka A, Huhn MH, Adelmann K, Kang YH, Fergusson JR, Simmonds P, Goulder P, Hansen TH, Fox J, Gunthard HF, Khanna N, Powrie F, Steel A, Gazzard B, Phillips RE, Frater J, Uhlig H, Klenerman P. Early and nonreversible decrease of CD161++ /MAIT cells in HIV infection. Blood. 2013 Feb 7;121(6):951-61. doi: 10.1182/blood-2012-06-436436. Epub 2012 Dec 18.

  • Leeansyah E, Ganesh A, Quigley MF, Sonnerborg A, Andersson J, Hunt PW, Somsouk M, Deeks SG, Martin JN, Moll M, Shacklett BL, Sandberg JK. Activation, exhaustion, and persistent decline of the antimicrobial MR1-restricted MAIT-cell population in chronic HIV-1 infection. Blood. 2013 Feb 14;121(7):1124-35. doi: 10.1182/blood-2012-07-445429. Epub 2012 Dec 13.

  • Meierovics AI, Cowley SC. MAIT cells promote inflammatory monocyte differentiation into dendritic cells during pulmonary intracellular infection. J Exp Med. 2016 Nov 14;213(12):2793-2809. doi: 10.1084/jem.20160637. Epub 2016 Oct 31.

  • Meierovics A, Yankelevich WJ, Cowley SC. MAIT cells are critical for optimal mucosal immune responses during in vivo pulmonary bacterial infection. Proc Natl Acad Sci U S A. 2013 Aug 13;110(33):E3119-28. doi: 10.1073/pnas.1302799110. Epub 2013 Jul 29.

  • Grimaldi D, Le Bourhis L, Sauneuf B, Dechartres A, Rousseau C, Ouaaz F, Milder M, Louis D, Chiche JD, Mira JP, Lantz O, Pene F. Specific MAIT cell behaviour among innate-like T lymphocytes in critically ill patients with severe infections. Intensive Care Med. 2014 Feb;40(2):192-201. doi: 10.1007/s00134-013-3163-x. Epub 2013 Dec 10.

  • Jiang J, Wang X, An H, Yang B, Cao Z, Liu Y, Su J, Zhai F, Wang R, Zhang G, Cheng X. Mucosal-associated invariant T-cell function is modulated by programmed death-1 signaling in patients with active tuberculosis. Am J Respir Crit Care Med. 2014 Aug 1;190(3):329-39. doi: 10.1164/rccm.201401-0106OC.

  • Kim JC, Jin HM, Cho YN, Kwon YS, Kee SJ, Park YW. Deficiencies of Circulating Mucosal-associated Invariant T Cells and Natural Killer T Cells in Patients with Acute Cholecystitis. J Korean Med Sci. 2015 May;30(5):606-11. doi: 10.3346/jkms.2015.30.5.606. Epub 2015 Apr 15.

  • Kwon YS, Cho YN, Kim MJ, Jin HM, Jung HJ, Kang JH, Park KJ, Kim TJ, Kee HJ, Kim N, Kee SJ, Park YW. Mucosal-associated invariant T cells are numerically and functionally deficient in patients with mycobacterial infection and reflect disease activity. Tuberculosis (Edinb). 2015 May;95(3):267-74. doi: 10.1016/j.tube.2015.03.004. Epub 2015 Mar 21.

  • Miyazaki Y, Miyake S, Chiba A, Lantz O, Yamamura T. Mucosal-associated invariant T cells regulate Th1 response in multiple sclerosis. Int Immunol. 2011 Sep;23(9):529-35. doi: 10.1093/intimm/dxr047. Epub 2011 Jun 28.

  • Cho YN, Kee SJ, Kim TJ, Jin HM, Kim MJ, Jung HJ, Park KJ, Lee SJ, Lee SS, Kwon YS, Kee HJ, Kim N, Park YW. Mucosal-associated invariant T cell deficiency in systemic lupus erythematosus. J Immunol. 2014 Oct 15;193(8):3891-901. doi: 10.4049/jimmunol.1302701. Epub 2014 Sep 15.

  • Serriari NE, Eoche M, Lamotte L, Lion J, Fumery M, Marcelo P, Chatelain D, Barre A, Nguyen-Khac E, Lantz O, Dupas JL, Treiner E. Innate mucosal-associated invariant T (MAIT) cells are activated in inflammatory bowel diseases. Clin Exp Immunol. 2014 May;176(2):266-74. doi: 10.1111/cei.12277.

  • Ruijing X, Mengjun W, Xiaoling Z, Shu P, Mei W, Yingcheng Z, Yuling H, Jinquan T. Jalpha33+ MAIT cells play a protective role in TNBS induced intestinal inflammation. Hepatogastroenterology. 2012 May;59(115):762-7. doi: 10.5754/hge11432.

  • Walsh AJ, Ghosh A, Brain AO, Buchel O, Burger D, Thomas S, White L, Collins GS, Keshav S, Travis SP. Comparing disease activity indices in ulcerative colitis. J Crohns Colitis. 2014 Apr;8(4):318-25. doi: 10.1016/j.crohns.2013.09.010. Epub 2013 Oct 10.

  • Feagan BG, Sandborn WJ, D'Haens G, Panes J, Kaser A, Ferrante M, Louis E, Franchimont D, Dewit O, Seidler U, Kim KJ, Neurath MF, Schreiber S, Scholl P, Pamulapati C, Lalovic B, Visvanathan S, Padula SJ, Herichova I, Soaita A, Hall DB, Bocher WO. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017 Apr 29;389(10080):1699-1709. doi: 10.1016/S0140-6736(17)30570-6. Epub 2017 Apr 12.

  • Gajendran M, Loganathan P, Catinella AP, Hashash JG. A comprehensive review and update on Crohn's disease. Dis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001. Epub 2017 Aug 18.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

AL- shimaa mohamed salahidden

CONTACT

wael Ahmed Abbas

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

November 14, 2022

Record last verified: 2022-11