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NCT07596680
ANCA Associated Vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT Number: NCT07157202
A cross-sectional, observational study aims to evaluate the relationship between Helicobacter pylori infection and disease activity in patients diagnosed with systemic lupus erythematosus (SLE), using a combination of structured patient interviews, standardized disease assessments, and laboratory detection of H. pylori by stool antigen testing .
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
the study explores the potential role of chronic H. pylori infection as a trigger or aggravating factor in SLE, an autoimmune disorder characterized by overactive immune responses that cause multisystem organ damage . The rationale is based on recent findings suggesting that chronic infections may worsen autoimmune disease activity by persistent immune stimulation and production of cross-reactive autoantibodies . SLE patients attending clinics at Assiut University Hospital will be assessed over one year; inclusion requires confirmed SLE diagnosis per established criteria, absence of recent antibiotics/PPIs, and consent. Clinical data, disease activity (via SLEDAI-2K), and socio-demographic information will be collected through detailed medical interviews and laboratory investigations, particularly focusing on stool-based antigen tests for H. pylori. All data will be securely recorded for statistical analysis assessing the bidirectional impact of infection status and SLE severity .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients who provide written informed consent to participate in the study. Patients who have not received antibiotics or proton pump inhibitors (PPIs) in the four weeks
Exclusion criteria
Time frame: baseline
The study will determine whether the presence or absence of H. pylori infection (measured by stool antigen test) is linked to higher disease activity in SLE, as quantified by the SLEDAI-2K score
Assiut University
Other
Association Between Helicobacter Pylori Infection and Disease Activity in Patients With Systemic Lupus Erythematosus (SLE)
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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.
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