Clinical trial NCT06352515: T Lymphocyte Subsets in Ulcerative Colitis
Official title: Peripheral Blood T Lymphocyte Subsets in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient \>18 years diagnosed with ulcerative colitis including newly diagnosed patients, patients on non-biologic immunosuppressive drugs, and patients on biological treatment.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study the distribution of T-cell subsets among ulcerative colitis patients.
timeFrame: 3 years
measure: Correlation of T-cell subtypes to therapeutic response
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Nadia Abdelwahab
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Asmaa Bakr
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Tarek Elmelegy
role: STUDY_DIRECTOR
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