Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06352515

T Lymphocyte Subsets in Ulcerative Colitis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow Cytometry

Diagnostic Test

flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients

Primary outcomes

  1. Study the distribution of T-cell subsets among ulcerative colitis patients.

    Time frame: 3 years

    Investigate and compare the distribution of different T-lymphocyte subsets among ulcerative colitis patients and healthy subjects .

  2. Correlation of T-cell subtypes to therapeutic response

    Time frame: 3 years

    Determine the effect of different treatment strategies used in UC on T-lymphocyte subsets

Study contacts

Contact information is provided by the study sponsor or research team.

Amany Abdelkader

CONTACT

[email protected]

+2 01001545631

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Peripheral Blood T Lymphocyte Subsets in Ulcerative Colitis

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.