Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT06659068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Seluang Fish Oil (Rasbora Argyrotaenia) and Synbiotics Supplementation on CD4+CD25+ Foxp3+ T-regulator Cells, IL17/IL-10 Ratio, and Disease Activity in Systemic Lupus Erythematosus Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Triple (Participant, Care Provider, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD4+CD25+Foxp3+ regulatory T cells,', 'timeFrame': 'From enrollment to the end of the treatment at 12 weeks', 'description': 'To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo in CD4+CD25+Foxp3+ regulatory T cells concentration change'}, {'measure': 'IL-17/IL-10 ratio', 'timeFrame': 'From enrollment to the end of the treatment at 12 weeks', 'description': 'To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo in IL-17/IL-10 ratio changes'}, {'measure': 'SLEDAI-2K score', 'timeFrame': 'From enrollment to the end of the treatment at 12 weeks', 'description': 'To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo towards SLEDAI-2K score changes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Seluang fish oil', 'Rasbora argyrotaenia', 'Systemic Lupus Erythematosus', 'SLE', 'IL-17/IL-10 ratio', 'CD4+', 'CD25+', 'Foxp3+', 'T-regulator', 'Disease Activity'], 'conditions': ['Systemic Lupus Erythematosus (SLE)']}, 'referencesModule': {'references': [{'pmid': '31198446', 'type': 'BACKGROUND', 'citation': 'Partan RU, Hidayat R, Saputra N, Rahmayani F, Prapto H, Yudha TW. Seluang Fish (Rasbora Spp.) Oil Decreases Inflammatory Cytokines Via Increasing Vitamin D Level in Systemic Lupus Erythematosus. Open Access Maced J Med Sci. 2019 May 5;7(9):1418-1421. doi: 10.3889/oamjms.2019.308. eCollection 2019 May 15.'}, {'pmid': '36359816', 'type': 'BACKGROUND', 'citation': 'Widhani A, Djauzi S, Suyatna FD, Dewi BE. Changes in Gut Microbiota and Systemic Inflammation after Synbiotic Supplementation in Patients with Systemic Lupus Erythematosus: A Randomized, Double-Blind, Placebo-Controlled Trial. Cells. 2022 Oct 29;11(21):3419. doi: 10.3390/cells11213419.'}, {'type': 'BACKGROUND', 'citation': 'Partan RU, Mart Salim E, Hidayat R. The potential role of seluang fish oil (Rasbora Spp) in improving calcium, zinc and vitamin d3 deficiencies. International Journal of Oceans and Oceanography. 2017: 11; 2. 285-29'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to evaluate the efficacy of seluang fish oil (Rasbora argyrotaenia) and synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation compared to placebo towards Systemic Lupus Erythematosus disease activity Index (SLEDAI)-2K score, IL-17/IL-10 ratio and CD4+ CD25+ Foxp3+T-regulator levels in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited 18-55 years old SLE patients diagnosed based on SLICC criteria, with mild to moderate disease activity, were clinically stable for ≥ 4 months (on prednison ≤ 20 mg/day or equivalent) and willingly ceased vitamin D and probiotic consumption during the trial study. Participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo. Evaluations were conducted on week 4, 8 and 12 for clinical symptoms, side effects and adherence. IL-17/IL-10 ratio and CD4+ CD25+ Foxp3+T-regulator levels were evaluated at the beginning and at the end of the 12 week trial for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who meet the SLICC criteria\n* Patients with mild to moderate SLE (mild if SLEDAI-2K score \\< 6 and moderate if SLEDAI-2K score: 6-12)\n* Aged 18-55 years\n* Willing to stop consuming vitamin D or multivitamin supplements containing vitamin D for at least 3 weeks before participating in the study\n* Willing to stop consuming probiotics that were previously taken for at least 1 week before participating in the study\n* If using prednisone, the dose must be stable (corticosteroid equivalent ≤ 20 mg/day) for at least 4 weeks before the study\n* Willing to sign informed consent\n\nExclusion Criteria:\n\n* Patients with severe SLE\n* Patients with SLE with hypercalcemia (\\> 2.60 mmol/l)\n* Patients with SLE with liver dysfunction: serum Aspartate Transferase (AST) - and Alanine Transferase (ALT) levels \\> 2 times the normal value or total serum bilirubin \\> 1.5 times the normal value\n* Patients undergoing hemodialysis or patients with serum creatinine \\> 2.5 mg/dL\n* Pregnant patients\n* Patients with SLE with immunocompromised conditions such as HIV\n* Patients with SLE with chronic infections such as pulmonary tuberculosis\n* Patients currently undergoing antibiotic therapy\n\nDrop out criteria:\n\n* Patients who have been off medication for more than 3 weeks\n* Patients who have passed away\n* Patients who consume yogurt or supplements containing probiotics/synbiotics more than once consecutively in 1 week\n* Patients who experience a change in immunosuppressive agents during the study\n* Patients who are hospitalized due to a worsening condition during the intervention period\n* Loss to follow-up'}, 'identificationModule': {'nctId': 'NCT06659068', 'briefTitle': 'Efficacy of Seluang Fish Oil (Rasbora Argyrotaenia) and Synbiotics Supplementation on CD4+CD25+ Foxp3+ T-regulator Cells, IL17/IL-10 Ratio, and Disease Activity in Systemic Lupus Erythematosus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sriwijaya'}, 'officialTitle': 'Efficacy of Seluang Fish Oil (Rasbora Argyrotaenia) and Synbiotics Supplementation on CD4+CD25+ Foxp3+ T-regulator Cells, IL17/IL-10 Ratio, and Disease Activity in Systemic Lupus Erythematosus Patients', 'orgStudyIdInfo': {'id': '4.3/D.XVIII.6.8/ETIK/208/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seluang fish oil (Rasbora argyrotaenia) and Synbiotic', 'description': 'Seluang fish oil (Rasbora argyrotaenia) and Synbiotic\n\nThe patients were given a capsule containing seluang fish oil (Rasbora argyrotaenia) once a day and also synbiotic once a day', 'interventionNames': ['Dietary Supplement: Seluang fish oil (Rasbora argyrotaenia) and synbiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo\n\nThe patients were given placebo capsules of seluang fish oil (Rasbora argyrotaenia) and synbiotics once a day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Seluang fish oil (Rasbora argyrotaenia) and synbiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients received seluang fish oil (Rasbora argyrotaenia) and synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation', 'armGroupLabels': ['Seluang fish oil (Rasbora argyrotaenia) and Synbiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received placebo capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30126', 'city': 'Palembang', 'state': 'South Sumatera', 'country': 'Indonesia', 'facility': 'Mohammad Hoesin General Hospital', 'geoPoint': {'lat': -2.91673, 'lon': 104.7458}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sriwijaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital', 'investigatorFullName': 'Yuniza', 'investigatorAffiliation': 'Universitas Sriwijaya'}}}}