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

NCT ID: NCT06586567

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2025-03-31

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

Conditions

Helicobacter Pylori Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 (SLE group):

50 patients fulfilling the1997 revised American Collage of Rheumatology classification criteria for SLE according to (Hochberg, 1997)., and h\_pylori positive

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

Intervention Type: OTHER

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

Group 2 (RA group):

50 RA patients diagnosed according to the American college of rheumatology (ACR)-EULAR RA classification criteria 2010. And H\_pylori positive

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

Intervention Type: OTHER

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

Group 3

50 heqlthy age and sex matched adults were selected as control group

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

Intervention Type: OTHER

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

Interventions

Full 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

Intervention Type: OTHER

Other Intervention Names

Upper endoscopy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Mostafa Mohamed Ahmed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Mostafa Mohamed Ahmed

Role: CONTACT

Fatmamostf32@gmail.com

01004313003

Husseian Ahmed Elamin

Role: CONTACT

elamin67@yahoo.com

01004084187

References

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.

Reference Type: BACKGROUND

PMID: 12839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 115691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3964 (View on PubMed)

Other Identifiers

H pylori and SlE and RA

Identifier Type: -

Identifier Source: org_study_id