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H-pylori Infection With Disease Activity in Systemic Lupus Erythematosus and Rheumatoid Arthritis

Association of Helicobacter Pylori Infection With Disease Activity in Systemic Lupus Erythrematosis and Rheumatoid Arthritis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06586567
Enrollment
150
Registered
2024-09-19
Start date
2024-09-04
Completion date
2025-03-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief summary

To find the relation of Helicobacter pylori with disease activity in SLE and RA

Detailed description

H. pylori is a widespread, spiral-shaped, flagellated Gram-negative bacterium usually infects the gastric mucosa.Its seropositivity increases with age as it affects about eighty percent of the middle-aged adults in the developing countries and about twenty-five to fifty percent in the western populations.The relation between infection and autoimmune diseases has been previously investigated. Many Gram-negative bacteria as salmonella, shigella, and chlamydia were confirmed to be associated with the development of reactive arthritis.These bacteria have been found to stimulate the host immune response due to the presence of lipopolysaccharides and other antigenic molecules that can cause inflammation.It has been previously hypothesized that H. pylori can induce such immune host response through many mechanisms as the molecular mimicry and antigenic similarity, disruption of the tolerogenic immune response, and activation of the polyclonal lymphocytes leading ultimately to the imbalance between T regulatory/Th17 cells in addition to the induction of autoantibody production

Interventions

OTHERFull history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas

2\. Complete clinical examination 3. Assessment of disease activity The following disease activity parameters were used to assess the current activity of each disease: * Disease activity score (DAS-28) for patients with RA. * SLE disease activity scale (SLEDAI) for patients with SLE. 4. Laboratory investigations: Complete blood count (CBC) Erythrocyte sedimentation rate (ESR). C-reactive protein (CRP) Serum creatinine and blood urea Random plasma glucose level Liver function tests Complete urine analysis. 24 hours urinary protein (g/day) 24 hours creatinine clearance Uric acid Complement 3& 4. Antinuclear antibody (ANA) Anti-dsDNA antibody Estimation of H.Pylori

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. patients with SLE and RA who were admitted to Rheumatology unit in Internal medicine department, Assuit University Hospital will be enrolled in this study

Exclusion criteria

* Any patient or control known to have treatment for H. pylori or taking antibiotic treatment for the previous three months 2- Patients receiving biologic therapy 3-Patients known to have diabetes mellitus, autoimmune thyroid disease or autoimmune hepatitis or any other autoimmune

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of activity of SLE and RA after treatment of H Pylori infection2 yearsPrevalence of activity of SLE and RA after treatment of H Pylori infection

Contacts

Primary ContactFatma Mostafa Mohamed Ahmed
Fatmamostf32@gmail.com01004313003
Backup ContactHusseian Ahmed Elamin
elamin67@yahoo.com01004084187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026