Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians

NCT07157202 | Not Yet Recruiting

• 1 other identifier: H. pylori and SLE
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

H. Pylori; SLE - Systemic Lupus Erythematosus

Keywords

SLE; H. pylori infection

Outcome Measures

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

  baseline

Study Arms (1)

adult patients with a confirmed diagnosis of SLE,

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 . Of those eligible, the expected sample size is 115 patients, calculated to power the main outcome analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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 .

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Dai X, Fan Y, Zhao X. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics. Signal Transduct Target Ther. 2025 Mar 17;10(1):102. doi: 10.1038/s41392-025-02168-0.

  PMID: 40097390 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the Internal Medicine department

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share