Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-28 @ 4:45 AM
Study NCT ID:
NCT05604469
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2022-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Skin Microbiota in Hepatic or Renal Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'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': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-30', 'studyFirstSubmitDate': '2022-10-30', 'studyFirstSubmitQcDate': '2022-10-30', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the possible change of skin microbiota in patients with renal or hepatic pruritus', 'timeFrame': '8 weeks', 'description': 'Isolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Failure', 'Hepatic Failure', 'Pruritus']}, 'referencesModule': {'references': [{'pmid': '15523377', 'type': 'BACKGROUND', 'citation': 'Szepietowski JC, Salomon J. Uremic pruritus: still an important clinical problem. J Am Acad Dermatol. 2004 Nov;51(5):842-3. doi: 10.1016/j.jaad.2004.04.003. No abstract available.'}, {'pmid': '12432992', 'type': 'BACKGROUND', 'citation': 'Szepietowski JC, Sikora M, Kusztal M, Salomon J, Magott M, Szepietowski T. Uremic pruritus: a clinical study of maintenance hemodialysis patients. J Dermatol. 2002 Oct;29(10):621-7. doi: 10.1111/j.1346-8138.2002.tb00191.x.'}, {'pmid': '26355256', 'type': 'BACKGROUND', 'citation': 'Combs SA, Teixeira JP, Germain MJ. Pruritus in Kidney Disease. Semin Nephrol. 2015 Jul;35(4):383-91. doi: 10.1016/j.semnephrol.2015.06.009.'}, {'type': 'BACKGROUND', 'citation': 'N. V. Bergasa. Frontiers in neuroscience pruritus of cholestasis. In: Carstens E, Akiyama T, editors. Itch: mechanisms and treatment. Boca Raton, FL: CRC Press/Taylor & Francis Group; 2014.'}, {'pmid': '32331207', 'type': 'BACKGROUND', 'citation': 'Kim HS, Yosipovitch G. The Skin Microbiota and Itch: Is There a Link? J Clin Med. 2020 Apr 22;9(4):1190. doi: 10.3390/jcm9041190.'}]}, 'descriptionModule': {'briefSummary': '* Various neurotransmitters may share in the pathogenesis of hepatic and renal itching.\n* Skin microbiota may share in the pathogenesis of pruritus.', 'detailedDescription': "Uremic pruritus (UP) is a frequent phenomenon and it is regarded as one of the most bothersome symptoms in patients with chronic renal disease. The prevalence of UP is still high and reported in around 40% to 50%. UP has an important impact on patients' quality of life and sleep, depression, and increased mortality. The pathogenesis of UP remains blurry, although many different factors have been indicated in the etiology of this symptom, including increased systemic inflammation, abnormal serum parathyroid hormone, calcium, and phosphorus levels, an imbalance in opiate receptors, a neuropathic process, or even skin dryness. This is why until now there is no specific treatment for patients with UP and many of the available therapeutic modalities are not satisfactory Pruritus in liver diseases can often be a debilitating symptom causing significant impairment in quality of life. Not all patients with liver disease develop pruritus and its prevalence varies depending on the underlying cause of liver disease. It is more common in conditions characterized by bile duct inflammatory destruction than in those characterized by hepatocellular injury.\n\nCutaneous microbiota delivers a diverse and far-reaching influence on our physiology by calling upon the host nervous system. Bacteria make metabolites, toxins, and structural components that are recognized by peripheral and central neurons via matching receptors. Microbiota also indirectly affects neural function by causing endocrine (i.e., keratinocytes) and immune cells to transmit signals (i.e., cytokines, proteases). Itch is a prototypic sensory neural function, and the microbiota propels the itch-scratch cycle."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.'}, 'identificationModule': {'nctId': 'NCT05604469', 'briefTitle': 'The Role of Skin Microbiota in Hepatic or Renal Pruritus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'The Role of Skin Microbiota in Patients With Hepatic or Renal Pruritus', 'orgStudyIdInfo': {'id': '9802-11-10-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A (liver faluire patients with pruritus)', 'description': 'Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury)', 'interventionNames': ['Diagnostic Test: Isolation of skin microbiota']}, {'label': 'Group B (liver faluire patients without pruritus)', 'description': 'Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury)', 'interventionNames': ['Diagnostic Test: Isolation of skin microbiota']}, {'label': 'Group C (renal faluire patients with pruritus)', 'interventionNames': ['Diagnostic Test: Isolation of skin microbiota']}, {'label': 'Group D (renal faluire patients without pruritus)', 'interventionNames': ['Diagnostic Test: Isolation of skin microbiota']}], 'interventions': [{'name': 'Isolation of skin microbiota', 'type': 'DIAGNOSTIC_TEST', 'description': 'Isolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida.', 'armGroupLabels': ['Group A (liver faluire patients with pruritus)', 'Group B (liver faluire patients without pruritus)', 'Group C (renal faluire patients with pruritus)', 'Group D (renal faluire patients without pruritus)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2543', 'city': 'Zagazig', 'state': 'Al Sharqia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Reham Essam', 'role': 'CONTACT', 'email': 'rereessam22@gmail.com', 'phone': '01097709477'}], 'facility': 'Reham Essam', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Reham Essam, MD', 'role': 'CONTACT', 'email': 'rereessam22@gmail.com', 'phone': '+201097709477'}, {'name': 'Reham Essam', 'role': 'CONTACT', 'email': 'rereessam22@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Dermatology', 'investigatorFullName': 'Reham Essam', 'investigatorAffiliation': 'Zagazig University'}}}}