T Lymphocyte Subsets in Ulcerative Colitis

NCT06352515 | Not Yet Recruiting

• 1 other identifier: T cells in Ulcerative colitis
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.
2. 2.Correlation of T-cell subsets to therapeutic response/ disease activity.
3. 3.Assess the value of circulating IgG anti-Integrin αvβ6 in UC.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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

• Correlation of T-cell subtypes to therapeutic response

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

  3 years

Study Arms (4)

Group I

Patients with newly diagnosed, active, untreated ulcerative colitis

Diagnostic Test: Flow cytometry

Group II

Ulcerative colitis patients on non-biologic immunosuppressive drugs.

Diagnostic Test: Flow cytometry

Group III

Ulcerative colitis patients on established biological treatment.

Diagnostic Test: Flow cytometry

Group IV

Age- and sex-matched healthy controls.

Diagnostic Test: Flow cytometry

Interventions

Flow cytometry DIAGNOSTIC_TEST

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

Group I; Group II; Group III; Group IV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients with clinical diagnosis of ulcerative colitis among both sexes.
• Age \>18 years Old.

You may not qualify if:

• Age \<18 years old.
• Patients who refuse to participate in the study.
• Patients who have other autoimmune disease.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 35906289 BACKGROUND

• 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.

  PMID: 37638002 BACKGROUND

• 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.

  PMID: 37897948 BACKGROUND

• 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.

  PMID: 33915494 BACKGROUND

• 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.

  PMID: 34536451 BACKGROUND

• 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.

  PMID: 34299236 BACKGROUND

• 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.

  PMID: 37407314 BACKGROUND

• 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.

  PMID: 32248339 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample will be stored at -70

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Nadia Abdelwahab

  Assiut University

  STUDY DIRECTOR

• Asmaa Bakr

  Assiut University

  STUDY DIRECTOR

• Tarek Elmelegy

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Amany Abdelkader

CONTACT

+2 01001545631; dr-amanyelhawary@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2024

Record last verified: 2024-04