T Lymphocyte Subsets in Ulcerative Colitis

April 26, 2024 updated by: Amany Abdelkader Ahmed, Assiut University

Peripheral Blood 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
Patients with newly diagnosed, active, untreated ulcerative colitis
Diagnostic test: Flow cytometry
flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients
Group II
Ulcerative colitis patients on non-biologic immunosuppressive drugs.
Diagnostic test: Flow cytometry
flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients
Group III
Ulcerative colitis patients on established biological treatment.
Diagnostic test: Flow cytometry
flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients
Group IV
Age- and sex-matched healthy controls.
Diagnostic test: Flow cytometry
flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Nadia Abdelwahab, Assiut University
  • Study Director: Asmaa Bakr, Assiut University
  • Study Director: Tarek Elmelegy, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T cells in Ulcerative colitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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