Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT07157202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between H. pylori infection status and SLE disease activity', 'timeFrame': 'baseline', 'description': 'The study will determine whether the presence or absence of H. pylori infection (measured by stool antigen test) is linked to higher disease activity in SLE, as quantified by the SLEDAI-2K score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLE', 'H. pylori infection'], 'conditions': ['H. Pylori', 'SLE - Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '40097390', 'type': 'BACKGROUND', 'citation': 'Dai X, Fan Y, Zhao X. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics. Signal Transduct Target Ther. 2025 Mar 17;10(1):102. doi: 10.1038/s41392-025-02168-0.'}]}, 'descriptionModule': {'briefSummary': 'A cross-sectional, observational study aims to evaluate the relationship between Helicobacter pylori infection and disease activity in patients diagnosed with systemic lupus erythematosus (SLE), using a combination of structured patient interviews, standardized disease assessments, and laboratory detection of H. pylori by stool antigen testing .', 'detailedDescription': 'the study explores the potential role of chronic H. pylori infection as a trigger or aggravating factor in SLE, an autoimmune disorder characterized by overactive immune responses that cause multisystem organ damage . The rationale is based on recent findings suggesting that chronic infections may worsen autoimmune disease activity by persistent immune stimulation and production of cross-reactive autoantibodies . SLE patients attending clinics at Assiut University Hospital will be assessed over one year; inclusion requires confirmed SLE diagnosis per established criteria, absence of recent antibiotics/PPIs, and consent. Clinical data, disease activity (via SLEDAI-2K), and socio-demographic information will be collected through detailed medical interviews and laboratory investigations, particularly focusing on stool-based antigen tests for H. pylori. All data will be securely recorded for statistical analysis assessing the bidirectional impact of infection status and SLE severity .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants are adults (at least 18 years old) diagnosed with SLE according to ACR or SLICC criteria, who have not used antibiotics or proton pump inhibitors in the past four weeks, and provide written informed consent . Patients with prior gastric surgery, GI cancer, immunosuppressive therapy for non-SLE conditions, coexisting autoimmune diseases, pregnancy or lactation, or any current active infection other than H. pylori at enrollment are excluded . Of those eligible, the expected sample size is 115 patients, calculated to power the main outcome analysis. Demographic details (age, sex, ethnicity, disease duration, smoking status, and family history) and clinical manifestations (SLE-related symptoms, medications, and organ involvement) will be thoroughly documented to ensure a well-characterized, representative population .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (aged ≥18 years) with a confirmed diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n\nPatients who provide written informed consent to participate in the study. Patients who have not received antibiotics or proton pump inhibitors (PPIs) in the four weeks\n\nExclusion Criteria:\n\n* Patients with a history of gastric surgery or known gastrointestinal malignancy.\n\n * Patients currently receiving immunosuppressive therapy for conditions other than SLE.\n * Patients with coexisting autoimmune diseases other than SLE.\n * Pregnant or lactating women.\n * Patients with active infections (other than H. pylori) at the time of enrollment.'}, 'identificationModule': {'nctId': 'NCT07157202', 'briefTitle': 'Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Association Between Helicobacter Pylori Infection and Disease Activity in Patients With Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': 'H. pylori and SLE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adult patients with a confirmed diagnosis of SLE,', 'description': 'Eligible participants are adults (at least 18 years old) diagnosed with SLE according to ACR or SLICC criteria, who have not used antibiotics or proton pump inhibitors in the past four weeks, and provide written informed consent . Of those eligible, the expected sample size is 115 patients, calculated to power the main outcome analysis.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the Internal Medicine department', 'investigatorFullName': 'Wanees Ebrahim', 'investigatorAffiliation': 'Assiut University'}}}}