Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-25 @ 7:16 PM
Study NCT ID:
NCT02417792
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2015-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Psoriasis and Intestinal Bacterial Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A significant change (P<0.05) in enteric bacterial composition of psoriasis patients (n=20) vs controls (n=20) as assessed by alpha diversity, beta diversity and taxonomic analysis.', 'timeFrame': '2 years', 'description': 'To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psoriasis', 'microbiota'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '23084703', 'type': 'BACKGROUND', 'citation': 'Shaw SY, Blanchard JF, Bernstein CN. Association between early childhood otitis media and pediatric inflammatory bowel disease: an exploratory population-based analysis. J Pediatr. 2013 Mar;162(3):510-4. doi: 10.1016/j.jpeds.2012.08.037. Epub 2012 Oct 17.'}, {'pmid': '20940708', 'type': 'BACKGROUND', 'citation': 'Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics in the first year of life and pediatric inflammatory bowel disease. Am J Gastroenterol. 2010 Dec;105(12):2687-92. doi: 10.1038/ajg.2010.398. Epub 2010 Oct 12.'}, {'pmid': '20383131', 'type': 'BACKGROUND', 'citation': 'Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Pena AG, Goodrich JK, Gordon JI, Huttley GA, Kelley ST, Knights D, Koenig JE, Ley RE, Lozupone CA, McDonald D, Muegge BD, Pirrung M, Reeder J, Sevinsky JR, Turnbaugh PJ, Walters WA, Widmann J, Yatsunenko T, Zaneveld J, Knight R. QIIME allows analysis of high-throughput community sequencing data. Nat Methods. 2010 May;7(5):335-6. doi: 10.1038/nmeth.f.303. Epub 2010 Apr 11. No abstract available.'}, {'pmid': '20709691', 'type': 'BACKGROUND', 'citation': 'Edgar RC. Search and clustering orders of magnitude faster than BLAST. Bioinformatics. 2010 Oct 1;26(19):2460-1. doi: 10.1093/bioinformatics/btq461. Epub 2010 Aug 12.'}, {'pmid': '4056119', 'type': 'BACKGROUND', 'citation': 'Henseler T, Christophers E. Psoriasis of early and late onset: characterization of two types of psoriasis vulgaris. J Am Acad Dermatol. 1985 Sep;13(3):450-6. doi: 10.1016/s0190-9622(85)70188-0.'}]}, 'descriptionModule': {'briefSummary': 'At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.', 'detailedDescription': 'Intestinal bacterial population has a significant influence on health and sickness conditions. It affects the development and the function of the immune system (Th2, Th1 or Th17) by bacterial protein expression and by the composition of the bacterial population.\n\nPsoriasis is an immune related dermal disease. The trigger for this disease is currently unknown but, it is possible that intestinal bacteria are a factor in its development.\n\nStudy design:\n\nParticipants will be divided into 3 groups:\n\n* Psoriasis patients treated with topical medications\n* Psoriasis patients treated with IV or sub-cutaneous medications (e.g biological medications)\n* Healthy participants (control group) Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dermal psoriasis patients diagnosed by a dermatologist.\n\nExclusion Criteria:\n\n* Treatment with antibiotics or probiotics within the prior 3 months.\n* incapable of signing an inform concent.'}, 'identificationModule': {'nctId': 'NCT02417792', 'acronym': 'PIB', 'briefTitle': 'The Association Between Psoriasis and Intestinal Bacterial Population', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Hospital Systems'}, 'officialTitle': 'The Association Between Psoriasis and Intestinal Bacterial Population', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'group of healthy participants'}, {'label': 'Topical psoriasis treatment', 'description': 'Group of patients who are treated with topical medications for psoriasis'}, {'label': 'Systemic psoriasis treatment', 'description': 'Group of patients who are treated with systematic medications for psoriasis'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jonathan Shapiro, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maccabi Healthcare Services, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Hospital Systems', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tel Aviv Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}