Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-30 @ 8:47 AM
Study NCT ID:
NCT05433857
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics in Systemic Lupus Erythematosus
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional, Prospective, randomized, controlled, open-label study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4'}], 'secondaryOutcomes': [{'measure': 'Improvement of immunologic parameters', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Anti-dsDNA levels'}, {'measure': 'Improvement of serum complement', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Complements 3 and 4'}, {'measure': "patients' quality of life", 'timeFrame': 'At baseline and at 12 weeks', 'description': "Assessment of patients' quality of life using the validated Arabic Lupus Patient-reported outcome survey version 1.8 (LupusPROv1.8)"}, {'measure': 'Pain assessment', 'timeFrame': 'At baseline and at 12 weeks', 'description': 'Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire'}, {'measure': 'Incidence of potential adverse effects', 'timeFrame': 'Weekly up to 12 weeks', 'description': 'Monitoring for side and/or adverse effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Lactobacillus', 'Systemic lupus erythematosus', 'SLEDAI-2K'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.', 'detailedDescription': '1. Patients will be recruited and evaluated for eligibility.\n2. Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.\n3. Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks.\n4. Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.\n5. Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study.\n6. Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.\n7. Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 years, male or female.\n2. Patients are willing to sign a written informed consent.\n3. Patients fulfilling American college of rheumatology classification criteria for SLE.\n4. Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.\n\nExclusion Criteria:\n\n1. Patients ˂ 18 years or ˃65 years of age.\n2. Patients with a history of drug allergies to probiotics administration.\n3. Pregnant or breastfeeding females.\n4. Current probiotics use.\n5. Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.\n6. patients suffering from active severe neuropsychiatric manifestations of SLE.\n7. Patients with other auto-immune diseases.\n8. Patients suffering from any type of cancer.\n9. patients participating in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT05433857', 'briefTitle': 'Probiotics in Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'RHDIRB2020110301 REC 80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '20 patients will receive the standard therapy for 12 weeks'}, {'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': '20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks', 'interventionNames': ['Drug: Lacteol forte capsules']}], 'interventions': [{'name': 'Lacteol forte capsules', 'type': 'DRUG', 'otherNames': ['lactobacillus delbruekii and lactobacillus fermentum'], 'description': 'probiotic Lacteol Forte® capsules (5 billion heat-killed Lactobacillus LB, corresponding to lactobacillus delbruekii and lactobacillus fermentum) Two capsules are To be taken once daily', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Abbasseya', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Rana Sayed, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Pharmacy, Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rana Sayed Fouad', 'investigatorAffiliation': 'Ain Shams University'}}}}