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NCT Number: NCT07157202

Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians

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 .

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged ≥18 years) with a confirmed diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification 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

  • Patients with a history of gastric surgery or known gastrointestinal malignancy.
  • Patients currently receiving immunosuppressive therapy for conditions other than SLE.
  • Patients with coexisting autoimmune diseases other than SLE.
  • Pregnant or lactating women.
  • Patients with active infections (other than H. pylori) at the time of enrollment.

Treatment and study plan

Primary outcomes

  1. Association between H. pylori infection status and SLE disease activity

    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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Association Between Helicobacter Pylori Infection and Disease Activity in Patients With Systemic Lupus Erythematosus (SLE)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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