Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-05-24 @ 5:57 AM
Study NCT ID:
NCT02796794
Status:
UNKNOWN
Last Update Posted:
2016-06-13
First Post:
2016-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Enteral Genistein Supplementation in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019833', 'term': 'Genistein'}], 'ancestors': [{'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-07', 'studyFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Tumor necrosis factor alpha serum levels', 'timeFrame': 'Baseline, at 24th hour and at 72nd hour', 'description': 'It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study'}, {'measure': 'Change in interleukin 1-beta serum levels', 'timeFrame': 'Baseline, at 24th hour and at 72nd hour', 'description': 'It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study'}, {'measure': 'Change in interleukin 6 serum levels', 'timeFrame': 'Baseline, at 24th hour and at 72nd hour', 'description': 'It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study'}, {'measure': 'Change in high-mobility group box 1 serum levels', 'timeFrame': 'Baseline, at 24th hour and at 72nd hour', 'description': 'It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study'}], 'secondaryOutcomes': [{'measure': 'Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections', 'timeFrame': 'From date of randomization until 12 weeks', 'description': 'Patients will be followed until they are discharged from the hospital or death.'}, {'measure': 'Length of intensive care unit and hospital stay (days)', 'timeFrame': 'From date of randomization until 12 weeks', 'description': 'Patients will be followed until they are discharged from the hospital or death.'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'From date of randomization until 12 weeks', 'description': 'Patients will be followed until they are discharged from the hospital or death.'}, {'measure': 'Intensive care unit mortality rate, hospital mortality rate', 'timeFrame': 'From date of randomization until 12 weeks', 'description': 'Patients will be followed until they are discharged from the hospital or death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Enteral nutrition', 'Genistein', 'Cytokine'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '24614013', 'type': 'BACKGROUND', 'citation': 'Souza LR, Silva E, Calloway E, Kucuk O, Rossi M, McLemore ML. Genistein protects hematopoietic stem cells against G-CSF-induced DNA damage. Cancer Prev Res (Phila). 2014 May;7(5):534-44. doi: 10.1158/1940-6207.CAPR-13-0295. Epub 2014 Mar 10.'}, {'pmid': '22397815', 'type': 'BACKGROUND', 'citation': 'Lazarevic B, Hammarstrom C, Yang J, Ramberg H, Diep LM, Karlsen SJ, Kucuk O, Saatcioglu F, Tasken KA, Svindland A. The effects of short-term genistein intervention on prostate biomarker expression in patients with localised prostate cancer before radical prostatectomy. Br J Nutr. 2012 Dec 28;108(12):2138-47. doi: 10.1017/S0007114512000384. Epub 2012 Mar 8.'}, {'pmid': '16847837', 'type': 'BACKGROUND', 'citation': 'Hong H, Landauer MR, Foriska MA, Ledney GD. Antibacterial activity of the soy isoflavone genistein. J Basic Microbiol. 2006;46(4):329-35. doi: 10.1002/jobm.200510073.'}, {'pmid': '23984731', 'type': 'BACKGROUND', 'citation': 'Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis', 'detailedDescription': 'Sepsis is a state develops as a response to severe infection with high mortality rate. Incidence of sepsis among patients admitted to hospitals is 2%. Annual incidence of sepsis is 50-95 for 100.000 population and incidence is increasing approximately 9% each year. Severe sepsis and septic shock is the most frequent reason for mortality in intensive care units (ICU). There is exaggerated and irregular host response in sepsis. Cytokines such as interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor-α, Interferon-γ and high mobility group box-1 are released as response to invading microorganisms and they play a major role in sepsis pathogenesis.\n\nSoybean proteins are used for prevention and treatment of cardiovascular diseases, osteoporosis and different cancer types.\n\nSoy isoflavones such as genistein, daidzein and glycitein are the main components for cancer prevention. Genistein is the dominant isoflavones.\n\nThe main mechanism for anti-inflammatory effect of genistein is related to transcription nuclear factor (NF-kB) and inhibition of chemokine-8. The risk for prostate cancer was proven to decrease in epidemiological studies.\n\nNF-kB plays a central role for inflammatory cytokine release, prevents apoptosis and induces tumor cell growth. The effect of topoisomerase II inhibitory chemotherapeutic agents is increased with NF-kB inhibition.\n\nHypothesis\n\n1. Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines.\n2. Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria: inclusion criteria:\n\n* Patients with sepsis above 18 years of age.\n* Expected duration of ICU survival more than 48 hours.\n* Patients receiving enteral nutrition (EN)\n* Sepsis diagnosis within first 12 hours\n\nExclusion Criteria:\n\n* Presence of thyroid dysfunction\n* Presence of hyperlipidemia\n* Patients with nill by mouth and not receiving enteral nutrition'}, 'identificationModule': {'nctId': 'NCT02796794', 'briefTitle': 'Effect of Enteral Genistein Supplementation in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis', 'orgStudyIdInfo': {'id': '2014/341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Genistein', 'description': 'Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition', 'interventionNames': ['Dietary Supplement: Genistein']}, {'type': 'OTHER', 'label': 'control', 'description': 'Control group are the patients receiving enteral nutrition', 'interventionNames': ['Other: enteral nutrition only']}], 'interventions': [{'name': 'Genistein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Total 30 patients will be included into the study They will be divided into two groups each containing 15 patients. Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition', 'armGroupLabels': ['Genistein']}, {'name': 'enteral nutrition only', 'type': 'OTHER', 'description': 'These are the patients receiving enteral nutrition', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kudret Dogru, MD', 'role': 'CONTACT', 'email': 'kdogru@erciyes.edu.tr', 'phone': '+90 352 207 6666', 'phoneExt': '20000'}, {'name': 'Emine Alp, MD', 'role': 'CONTACT', 'email': 'ealp@erciyes.edu.tr', 'phone': '+90 352 207 6666', 'phoneExt': '20000'}], 'facility': 'Erciyes University Medical School', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Kursat Gundogan, MD', 'role': 'CONTACT', 'email': 'kgundogan@erciyes.edu.tr', 'phone': '+90 352 207 6666', 'phoneExt': '21919'}, {'name': 'Murat Sungur, MD', 'role': 'CONTACT', 'email': 'msungur@erciyes.edu.tr', 'phone': '+90 352 207 6666', 'phoneExt': '21912'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kursat Gundogan', 'investigatorAffiliation': 'TC Erciyes University'}}}}