Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-27 @ 10:58 AM
Study NCT ID:
NCT04411758
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2020-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propolis for Patients With Chronic Kidney Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011429', 'term': 'Propolis'}], 'ancestors': [{'id': 'D012116', 'term': 'Resins, Plant'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In this clinical trial, participants with CKD undergoing hemodialysis or peritoneal dialysis will be instructed to use 4 capsules of 500mg/day containing concentrated and standardized dry green propolis extract (EPP-AF®) for 2 months or placebo (4 capsules of 500mg/day of magnesium stearate, silicon dioxide and microcrystalline cellulose) for two months, and then the groups will be crossed and will receive the same amount of propolis as the first group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cytokines plasma levels measured by ELISA after supplementation with propolis.', 'timeFrame': '4 months', 'description': 'IL-6, Tumor necrosis factor (TNF)'}, {'measure': 'Change the expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome, peroxisome proliferator-activated receptor-γ', 'timeFrame': '4 months', 'description': 'nuclear factor (NF)-kappa B'}, {'measure': 'Change the profile of the intestinal microbiota of stool samples', 'timeFrame': '4 months', 'description': 'uremic toxins'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'non-dialysis', 'propolis', 'inflammation'], 'conditions': ['Chronic Kidney Diseases', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '39453192', 'type': 'DERIVED', 'citation': 'Fonseca L, Ribeiro M, Schultz J, Borges NA, Cardozo L, Leal VO, Ribeiro-Alves M, Paiva BR, Leite PEC, Sanz CL, Kussi F, Nakao LS, Rosado A, Stenvinkel P, Mafra D. Effects of Propolis Supplementation on Gut Microbiota and Uremic Toxin Profiles of Patients Undergoing Hemodialysis. Toxins (Basel). 2024 Sep 25;16(10):416. doi: 10.3390/toxins16100416.'}, {'pmid': '36934668', 'type': 'DERIVED', 'citation': 'Baptista BG, Fanton S, Ribeiro M, Cardozo LF, Regis B, Alvarenga L, Ribeiro-Alves M, Berretta AA, Shiels PG, Mafra D. The effect of Brazilian Green Propolis extract on inflammation in patients with chronic kidney disease on peritoneal dialysis: A randomised double-blind controlled clinical trial. Phytomedicine. 2023 Jun;114:154731. doi: 10.1016/j.phymed.2023.154731. Epub 2023 Mar 1.'}, {'pmid': '36708650', 'type': 'DERIVED', 'citation': 'Chermut TR, Fonseca L, Figueiredo N, de Oliveira Leal V, Borges NA, Cardozo LF, Correa Leite PE, Alvarenga L, Regis B, Delgado A, Berretta AA, Ribeiro-Alves M, Mafra D. Effects of propolis on inflammation markers in patients undergoing hemodialysis: A randomized, double-blind controlled clinical trial. Complement Ther Clin Pract. 2023 May;51:101732. doi: 10.1016/j.ctcp.2023.101732. Epub 2023 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of propolis extract on inflammation in participants with chronic kidney disease.\n\nSpecific objectives\n\nTo assess before and after the intervention period:\n\n* The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome proliferator-activated receptor-γ, as well as the levels of inflammatory cytokines (IL-6, Tumor nuclear factor-α, C-reactive protein, interleukin 1) and E-selectin adhesion molecules;\n* The levels of protein expression of inflammatory markers and antioxidant enzymes;\n* The profile of the intestinal microbiota of stool samples from the research participants;\n* Plasma levels of substances reactive to thiobarbituric acid and oxidized low density lipoprotein as a marker of oxidative stress;\n* Routine and anthropometric laboratory variables, indicative of the metabolic profile of the research participants;\n* Assess blood pressure, 6-minute walk test, recovery heart rate and chair lift test to assess the functional capacity of the research participants;\n* Assess atherogenic risk;\n* Food intake and nutritional status; Compare data between the intervention and control groups.', 'detailedDescription': 'Chronic kidney disease (CKD) has chronic systemic inflammation as an important component of multifactorial origin, a factor related to both the progression and outcomes of CKD, being involved in all causes of mortality in these patients, such as cardiovascular disease. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation, starting from the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation and oxidative stress, factors that feed on each other. In view of this scenario, propolis, a substance made up of a combination of several chemical components with broad potential biological activity, appears as a promising alternative to modulate inflammation in patients with CKD. However, clinical evidence to assess the effects of propolis in patients with CKD is scarce, and there are no studies that have investigated its effects on gene expression and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of propolis alcoholic extract on transcription factors and inflammatory markers in patients with CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Aged 18 years or older\n\n\\- with fistula arteriovenous\n\nExclusion Criteria:\n\n* Patients pregnant\n* Smokers\n* Using antibiotics in the last three months\n* Using antioxidant supplements as antioxidant vitamins, probiotic, prebiotic, symbiotic and antibiotics in the last three months\n* Clinical diagnosis of infectious diseases\n* Clinical diagnosis of Cancer\n* Clinical diagnosis of AIDS - for PD patients - no peritonitis'}, 'identificationModule': {'nctId': 'NCT04411758', 'briefTitle': 'Propolis for Patients With Chronic Kidney Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal Fluminense'}, 'officialTitle': 'Propolis as a New Strategy in Modulating Inflammation in Patients With Chronic Kidney Disease.', 'orgStudyIdInfo': {'id': 'Denise Mafra8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Patients will receive 4 capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Propolis Group', 'description': 'Patients will receive 4 capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months', 'interventionNames': ['Dietary Supplement: Propolis']}], 'interventions': [{'name': 'Propolis', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Four capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months and after washout, more two months crossover', 'armGroupLabels': ['Propolis Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Four capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months and after washout, more two months crossover', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niterói', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Denise Mafra', 'geoPoint': {'lat': -22.88333, 'lon': -43.10361}}], 'overallOfficials': [{'name': 'Denise Mafra, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal Fluminense'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal Fluminense', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}