Ulcerative ColitisNCT06352515
T Lymphocyte Subsets in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Flow cytometry
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient >18 years diagnosed with ulcerative colitis including newly diagnosed patients, patients on non-biologic immunosuppressive drugs, and patients on biological treatment.
Who may be able to join
- patients with clinical diagnosis of ulcerative colitis among both sexes.
- Age >18 years Old.
Who cannot join
- Age <18 years old.
- Patients who refuse to participate in the study.
- Patients who have other autoimmune disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Peripheral Blood T Lymphocyte Subsets in Ulcerative Colitis
- Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.
- Correlation of T-cell subsets to therapeutic response/ disease activity.
- Assess the value of circulating IgG anti-Integrin αvβ6 in UC.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Flow cytometry
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometryDiagnostic test
flow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients with newly diagnosed, active, untreated ulcerative colitis Receives: Diagnostic Test: Flow cytometry | |
| Group II | Ulcerative colitis patients on non-biologic immunosuppressive drugs. Receives: Diagnostic Test: Flow cytometry | |
| Group III | Ulcerative colitis patients on established biological treatment. Receives: Diagnostic Test: Flow cytometry | |
| Group IV | Age- and sex-matched healthy controls. Receives: Diagnostic Test: Flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 3 years
Correlation of T-cell subtypes to therapeutic response
Determine the effect of different treatment strategies used in UC on T-lymphocyte subsets
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Abdelkader Ahmed, Assiut University
- Investigators
- Nadia Abdelwahab, Study director, Assiut UniversityAsmaa Bakr, Study director, Assiut UniversityTarek Elmelegy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352515
- Sponsor's protocol ID
- T cells in Ulcerative colitis
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35906289Huang 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.
PubMed 37638002Fan 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.
PubMed 37897948Hua 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.
PubMed 33915494Yang 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.
PubMed 34536451Saez 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.
PubMed 34299236Marafini 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.
PubMed 37407314Dulic 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.
PubMed 32248339
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood T Lymphocyte Subsets in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06352515
- Acronym / sponsor ID
- T cells in Ulcerative colitis
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.
- Correlation of T-cell subsets to therapeutic response/ disease activity.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Flow cytometryPatients with newly diagnosed, active, untreated ulcerative colitis |
| Group II | – | Diagnostic Test: Flow cytometryUlcerative colitis patients on non-biologic immunosuppressive drugs. |
| Group III | – | Diagnostic Test: Flow cytometryUlcerative colitis patients on established biological treatment. |
| Group IV | – | Diagnostic Test: Flow cytometryAge- and sex-matched healthy controls. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient >18 years diagnosed with ulcerative colitis including newly diagnosed patients, patients on non-biologic immunosuppressive drugs, and patients on biological treatment.
Key inclusion criteria (2 listed)
- patients with clinical diagnosis of ulcerative colitis among both sexes.
- Age >18 years Old.
Key exclusion criteria (3 listed)
- Age <18 years old.
- Patients who refuse to participate in the study.
- Patients who have other autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow cytometryflow cytometry to study distribution of T lymphocyte subsets in ulcerative colitis patients | Diagnostic test | Group I, Group II, Group III, Group IV |
Primary outcome
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 .
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 35906289Adolph 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.
- Background: PubMed 37638002Huang 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.
- Background: PubMed 37897948Fan 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.
- Background: PubMed 33915494Hua 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.
- Background: PubMed 34536451Yang 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.
- Background: PubMed 34299236Saez 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.
- Background: PubMed 37407314Marafini 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.
- Background: PubMed 32248339Dulic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia Abdelwahab study director
Assiut University
Asmaa Bakr study director
Assiut University
Tarek Elmelegy study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany Abdelkader (+2 01001545631, dr-amanyelhawary@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the distribution of T-cell subsets among ulcerative colitis patients. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06352515, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.