Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06586567

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

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

Inclusion criteria

  • 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

Treatment and study plan

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

Other
  • 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

Other names: Upper endoscopy

Primary outcomes

  1. Prevalence of activity of SLE and RA after treatment of H Pylori infection

    Time frame: 2 years

    Prevalence of activity of SLE and RA after treatment of H Pylori infection

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Mostafa Mohamed Ahmed

CONTACT

[email protected]

01004313003

Husseian Ahmed Elamin

CONTACT

[email protected]

01004084187

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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.

Published trials that share one or more normalized conditions with this study.