Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT07157202
Brief Summary:
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 .
Detailed Description:
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 .
Study:
NCT07157202
Study Brief:
Protocol Section:
NCT07157202