- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368351
Bacteriotherapy in the Treatment of COVID-19 (BACT-ovid)
Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19
In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge.
Given 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.
This 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.
The 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Given the limited treatment options currently available, the search for resources capable of improving disease outcomes is fundamental for the management of patients
Systemic 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.
Moreover some strains of lactobacilli and bifidobacteria inhibit influenza virus, rhinovirus, respiratory syncytial virus, adenovirus, and pneumovirus .
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Rome, Italy, 00161
- Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- COVID-19 diagnosis
- symptomatic COVID-19
- hospitalization in infectious diseases wards
Exclusion Criteria:
- Pregnant
- hospitalization in Intensive Care Unit
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Standard of care
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.
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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)
dose: 200 mg, 1 cp x 2 / day
|
bacteriotherapy
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.
|
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)
dose: 200 mg, 1 cp x 2 / day
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delta of time of disappearance of acute diarrhea
Time Frame: 21 days
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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.
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21 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delta in the number of patients requiring orotracheal intubation despite treatment
Time Frame: 21 days
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Comparison between the two groups
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21 days
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Delta of crude mortality
Time Frame: 21 days
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Comparison between the two groups
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21 days
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Delta of length of stay for patients in hospital
Time Frame: 21 days
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Comparison between the two groups
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21 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriella d'Ettorre, MD, PhD, University of Rome Sapienza - Policlinico Umberto I Rome (Italy)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- Signs and Symptoms, Digestive
- COVID-19
- Pneumonia
- Diarrhea
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Azithromycin
- Hydroxychloroquine
Other Study ID Numbers
- DPHID-UniRoma05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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