Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04368351
Status:
UNKNOWN
Last Update Posted:
2020-05-04
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bacteriotherapy in the Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delta of time of disappearance of acute diarrhea', 'timeFrame': '21 days', 'description': 'Comparison between the two groups. Acute diarrhea was defined as a stool with increased water content, volume, or frequency that lasts less than 14 days.'}], 'secondaryOutcomes': [{'measure': 'Delta in the number of patients requiring orotracheal intubation despite treatment', 'timeFrame': '21 days', 'description': 'Comparison between the two groups'}, {'measure': 'Delta of crude mortality', 'timeFrame': '21 days', 'description': 'Comparison between the two groups'}, {'measure': 'Delta of length of stay for patients in hospital', 'timeFrame': '21 days', 'description': 'Comparison between the two groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 pneumonia', 'gut-lung axis', 'microbiome'], 'conditions': ['COVID', 'Pneumonia', 'Diarrhea']}, 'referencesModule': {'references': [{'pmid': '25922396', 'type': 'RESULT', 'citation': 'Patel R, DuPont HL. New approaches for bacteriotherapy: prebiotics, new-generation probiotics, and synbiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S108-21. doi: 10.1093/cid/civ177.'}, {'pmid': '27020282', 'type': 'RESULT', 'citation': 'Jiang X, Hou X, Tang L, Jiang Y, Ma G, Li Y. A phase trial of the oral Lactobacillus casei vaccine polarizes Th2 cell immunity against transmissible gastroenteritis coronavirus infection. Appl Microbiol Biotechnol. 2016 Sep;100(17):7457-69. doi: 10.1007/s00253-016-7424-9. Epub 2016 Mar 28.'}, {'pmid': '32334392', 'type': 'RESULT', 'citation': 'Jayawardena R, Sooriyaarachchi P, Chourdakis M, Jeewandara C, Ranasinghe P. Enhancing immunity in viral infections, with special emphasis on COVID-19: A review. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. Epub 2020 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge.\n\nGiven the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research.\n\nThis is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases.\n\nThe main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.', 'detailedDescription': 'Italy was the first European country hit by the severe outbreak of the SARS-CoV-2 epidemic emerged from China, with a high morbidity and associated mortality.\n\nGiven the limited treatment options currently available, the search for resources capable of improving disease outcomes is fundamental for the management of patients\n\nSystemic inflammation related to COVID-19, dietary changes, and use of antibiotics are all variables that contribute to changes in the gut microbiota with significant impact on the disease outcomes. Probiotic supplementation can help to correct these issues.\n\nMoreover some strains of lactobacilli and bifidobacteria inhibit influenza virus, rhinovirus, respiratory syncytial virus, adenovirus, and pneumovirus .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic patients affected by COVID-19 admitted to Policlinico Umberto I, University of Rome "Sapienza" (Italy), between March 14, 2020 and April 4, 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 diagnosis\n* symptomatic COVID-19\n* hospitalization in infectious diseases wards\n\nExclusion Criteria:\n\n* Pregnant\n* hospitalization in Intensive Care Unit'}, 'identificationModule': {'nctId': 'NCT04368351', 'acronym': 'BACT-ovid', 'briefTitle': 'Bacteriotherapy in the Treatment of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19', 'orgStudyIdInfo': {'id': 'DPHID-UniRoma05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of care', 'description': 'Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day.', 'interventionNames': ['Drug: Azithromycin', 'Drug: hydroxychloroquine']}, {'label': 'bacteriotherapy', 'description': 'Dietary Supplement: SivoMixx (200 billion) plus Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), and hydroxychloroquine cp 200 mg, 1 cp x 2 / day.', 'interventionNames': ['Dietary Supplement: SivoMixx (200 billion)', 'Drug: Azithromycin', 'Drug: hydroxychloroquine']}], 'interventions': [{'name': 'SivoMixx (200 billion)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code)', 'armGroupLabels': ['bacteriotherapy']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': 'dose: 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day)', 'armGroupLabels': ['Standard of care', 'bacteriotherapy']}, {'name': 'hydroxychloroquine', 'type': 'DRUG', 'description': 'dose: 200 mg, 1 cp x 2 / day', 'armGroupLabels': ['Standard of care', 'bacteriotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': "Gabriella d'Ettorre, MD, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rome Sapienza - Policlinico Umberto I Rome (Italy)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, MSc', 'investigatorFullName': 'Giancarlo Ceccarelli', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}