Clinical trial NCT06586567: H-pylori Infection With Disease Activity in Systemic Lupus Erythematosus and Rheumatoid Arthritis
Official title: Association of Helicobacter Pylori Infection With Disease Activity in Systemic Lupus Erythrematosis and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Helicobacter Pylori Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient of RA and SLE above the age of 18 yrs Presented with hyplori 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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of activity of SLE and RA after treatment of H Pylori infection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fontes M. Purification and properties of acid phosphatases isolated from Owenia fusiformis. Biochimie. 1976;58(10):1155-8. doi: 10.1016/s0300-9084(76)80113-7.
citation: Hahn P, Vikterlof KJ, Rydman H, Beckman KW, Blom O. The value of whole body bone scan in the pre-operative assessment in carcinoma of the breast. Eur J Nucl Med. 1979 Jun 1;4(3):207-10. doi: 10.1007/BF00620487.
citation: Zanchetti A, Stella A, Leonetti G, Morganti A, Terzoli L. Control of renin release: a review of experimental evidence and clinical implications. Am J Cardiol. 1976 Mar 31;37(4):675-91. doi: 10.1016/0002-9149(76)90413-6.