T Lymphocyte Subsets in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Peripheral Blood T Lymphocyte Subsets in Ulcerative Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352515
• Other study ID #: T cells in Ulcerative colitis
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Amany Abdelkader
• Phone: +2 01001545631
• Email: dr-amanyelhawary[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.

2. Correlation of T-cell subsets to therapeutic response/ disease activity.

3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC.

Description:

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine, frequently involving the rectum, and characterized by chronic and recurrent mucosal inflammation and ulceration. Although its cause is not well understood, current evidence suggests innate and adaptive immunity play critical roles in its pathogenesis.

One of the main classes of immune cells that are affected by and contribute to UC is T cells. T-lymphocytes comprise a complex collection of highly differentiated T-cell subsets playing key roles in the regulation and the effector phase of the immune response. CD4+ T cells were found over-activated and proliferated in UC patients, which can induce disorders of the cytokine network and increase the occurrence of colitis.

Once intestinal pathogens or inflammatory mediators are not cleared in time, pro-inflammatory mononuclear phagocytes (MNPs) or polymorphonuclear leukocytes (PMNs) are often recruited to promote the polarization of naive CD4+ T cells into Th1, Th2, Th17, Treg and other subsets of cells.

The balances Th17/ Treg cells are important for maintaining intestinal homeostasis. Once the proportion Th17 cells increases, it often induces the production of pro-inflammatory cytokines that promote colonic inflammation, whereas Treg cells are usually secrete interleukin-10 (IL-10) and transforming growth factor-β (TGF-β) for anti-inflammatory regulations.

UC-associated inflammation is also characterized by huge number of activated B cells and plasma cells, the latter being involved in the production of cytotoxic granules, immunoglobulins, and various autoantibodies, Recent studies have highlighted a novel autoantibody against integrin αvβ6 in the serum of patients diagnosed with UC.

Recently, targeting immune cells to inhibit inflammation has become a research hotspot. Biological therapies are highly effective hallmark therapies in UC. Despite their widespread use, the impact of these agents on the composition of the adaptive immune system is largely unexplored. Knowledge on such effects in UC could clarify the mechanism of action of these therapies, provide information about the status of the adaptive immune system, and could help finding cell-based markers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with clinical diagnosis of ulcerative colitis among both sexes.

• Age >18 years Old.

Exclusion Criteria:

• Age <18 years old.

• Patients who refuse to participate in the study.

• Patients who have other autoimmune disease.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Flow cytometry
flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Adolph TE, Meyer M, Schwarzler J, Mayr L, Grabherr F, Tilg H. The metabolic nature of inflammatory bowel diseases. Nat Rev Gastroenterol Hepatol. 2022 Dec;19(12):753-767. doi: 10.1038/s41575-022-00658-y. Epub 2022 Jul 29. — View Citation

Dulic S, Toldi G, Sava F, Kovacs L, Molnar T, Milassin A, Farkas K, Rutka M, Balog A. Specific T-Cell Subsets Can Predict the Efficacy of Anti-TNF Treatment in Inflammatory Bowel Diseases. Arch Immunol Ther Exp (Warsz). 2020 Apr 4;68(2):12. doi: 10.1007/s00005-020-00575-5. — View Citation

Fan Q, Dai W, Li M, Wang T, Li X, Deng Z, Li W, Li M. Inhibition of alpha2,6-sialyltransferase relieves symptoms of ulcerative colitis by regulating Th17 cells polarization. Int Immunopharmacol. 2023 Dec;125(Pt A):111130. doi: 10.1016/j.intimp.2023.111130. Epub 2023 Oct 26. — View Citation

Hua Y, Liu R, Lu M, Guan X, Zhuang S, Tian Y, Zhang Z, Cui L. Juglone regulates gut microbiota and Th17/Treg balance in DSS-induced ulcerative colitis. Int Immunopharmacol. 2021 Aug;97:107683. doi: 10.1016/j.intimp.2021.107683. Epub 2021 Apr 26. — View Citation

Huang J, Wang F, Tang X. Uncovering the shared molecule and mechanism between ulcerative colitis and atherosclerosis: an integrative genomic analysis. Front Immunol. 2023 Aug 10;14:1219457. doi: 10.3389/fimmu.2023.1219457. eCollection 2023. — View Citation

Marafini I, Laudisi F, Salvatori S, Lavigna D, Venuto C, Giannarelli D, Monteleone G. Diagnostic value of anti-integrin alphavbeta6 antibodies in ulcerative colitis. Dig Liver Dis. 2024 Jan;56(1):55-60. doi: 10.1016/j.dld.2023.06.024. Epub 2023 Jul 6. — View Citation

Saez A, Gomez-Bris R, Herrero-Fernandez B, Mingorance C, Rius C, Gonzalez-Granado JM. Innate Lymphoid Cells in Intestinal Homeostasis and Inflammatory Bowel Disease. Int J Mol Sci. 2021 Jul 16;22(14):7618. doi: 10.3390/ijms22147618. — View Citation

Yang W, Liu H, Xu L, Yu T, Zhao X, Yao S, Zhao Q, Barnes S, Cohn SM, Dann SM, Zhang H, Zuo X, Li Y, Cong Y. GPR120 Inhibits Colitis Through Regulation of CD4+ T Cell Interleukin 10 Production. Gastroenterology. 2022 Jan;162(1):150-165. doi: 10.1053/j.gastro.2021.09.018. Epub 2021 Sep 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the distribution of T-cell subsets among ulcerative colitis patients.	Investigate and compare the distribution of different T-lymphocyte subsets among ulcerative colitis patients and healthy subjects .	3 years
Primary	Correlation of T-cell subtypes to therapeutic response	Determine the effect of different treatment strategies used in UC on T-lymphocyte subsets	3 years