Helicobacter Pylori InfectionNCT06586567
H-pylori Infection With Disease Activity in Systemic Lupus Erythematosus and Rheumatoid Arthritis
An observational study of Helicobacter Pylori Infection, run by Assiut University.
Trial summary
To find the relation of Helicobacter pylori with disease activity in SLE and RA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2024to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient of RA and SLE above the age of 18 yrs Presented with hyplori infection
Who may be able to join
- patients with SLE and RA who were admitted to Rheumatology unit in Internal medicine department, Assuit University Hospital will be enrolled in this study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association of Helicobacter Pylori Infection With Disease Activity in Systemic Lupus Erythrematosis and Rheumatoid Arthritis
To find the relation of Helicobacter pylori with disease activity in SLE and RA
Read the detailed description
- 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
- Being tested
- Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plasOther
Also called Upper endoscopy
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Sep 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mostafa Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586567
- Sponsor's protocol ID
- H pylori and SlE and RA
- Status last verified
- Sep 2024
- First submitted
- 6 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12839Hahn 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.
PubMed 115691Zanchetti 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.
PubMed 3964
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Helicobacter Pylori Infection With Disease Activity in Systemic Lupus Erythrematosis and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06586567
- Acronym / sponsor ID
- H pylori and SlE and RA
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find the relation of Helicobacter pylori with disease activity in SLE and RA
Detailed description
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (SLE group): | – | Other: Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas50 patients fulfilling the1997 revised American Collage of Rheumatology classification criteria for SLE according to (Hochberg, 1997)., and h_pylori positive |
| Group 2 (RA group): | – | Other: Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas50 RA patients diagnosed according to the American college of rheumatology (ACR)-EULAR RA classification criteria 2010. And H_pylori positive |
| Group 3 | – | Other: Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas50 heqlthy age and sex matched adults were selected as control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient of RA and SLE above the age of 18 yrs Presented with hyplori infection
Key inclusion criteria (1 listed)
- patients with SLE and RA who were admitted to Rheumatology unit in Internal medicine department, Assuit University Hospital will be enrolled in this study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plasAlso: Upper endoscopy2. 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 | Group 1 (SLE group):, Group 2 (RA group):, Group 3 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 12839Fontes 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.
- Background: PubMed 115691Hahn 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.
- Background: PubMed 3964Zanchetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Mostafa Mohamed Ahmed (01004313003, Fatmamostf32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of activity of SLE and RA after treatment of H Pylori infection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06586567, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.