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T Lymphocyte Subsets in Ulcerative Colitis

A

Assiut University

Status

Not yet enrolling

Conditions

Ulcerative Colitis

Treatments

Diagnostic Test: Flow cytometry

Study type

Observational

Funder types

Other

Identifiers

NCT06352515
T cells in Ulcerative colitis

Details and patient eligibility

About

  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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

80 participants in 4 patient groups

Group I
Description:
Patients with newly diagnosed, active, untreated ulcerative colitis
Treatment:
Diagnostic Test: Flow cytometry
Group II
Description:
Ulcerative colitis patients on non-biologic immunosuppressive drugs.
Treatment:
Diagnostic Test: Flow cytometry
Group III
Description:
Ulcerative colitis patients on established biological treatment.
Treatment:
Diagnostic Test: Flow cytometry
Group IV
Description:
Age- and sex-matched healthy controls.
Treatment:
Diagnostic Test: Flow cytometry

Trial contacts and locations

0

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Central trial contact

Amany Abdelkader

Data sourced from clinicaltrials.gov

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