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

NCT06586567 | Not Yet Recruiting

• 1 other identifier: H pylori and SlE and RA
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

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

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

  2 years

Study Arms (3)

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

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

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

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

Group 3

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

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

Interventions

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

Also known as: Upper endoscopy

Group 1 (SLE group):; Group 2 (RA group):; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient of RA and SLE above the age of 18 yrs Presented with hyplori infection

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 12839 BACKGROUND

• 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.

  PMID: 115691 BACKGROUND

• 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.

  PMID: 3964 BACKGROUND

MeSH Terms

Interventions

Restraint, Physical; Blood Cell Count; Blood Urea Nitrogen; Gastroscopy

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Kidney Function Tests; Diagnostic Techniques, Urological; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Fatma Mostafa Mohamed Ahmed

CONTACT

01004313003; Fatmamostf32@gmail.com

Husseian Ahmed Elamin

CONTACT

01004084187; elamin67@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: September 19, 2024
• Study Start: September 4, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09