Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Eligible participants are adults (at least 18 years old) diagnosed with SLE according to ACR or SLICC criteria, who have not used antibiotics or proton pump inhibitors in the past four weeks, and provide written informed consent . Patients with prior gastric surgery, GI cancer, immunosuppressive therapy for non-SLE conditions, coexisting autoimmune diseases, pregnancy or lactation, or any current active infection other than H. pylori at enrollment are excluded . Of those eligible, the expected sample size is 115 patients, calculated to power the main outcome analysis. Demographic details (age, sex, ethnicity, disease duration, smoking status, and family history) and clinical manifestations (SLE-related symptoms, medications, and organ involvement) will be thoroughly documented to ensure a well-characterized, representative population .
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
115 Participants
are grouped into 1 trial groupGroup A: adult patients with a confirmed diagnosis of SLE,
Trial outcomes
Primary outcomes
1
Association between H. pylori infection status and SLE disease activity
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
Time frame
baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: