Bacteriotherapy in the Treatment of COVID-19 (BACT-ovid)
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ClinicalTrials.gov Identifier: NCT04368351 |
Recruitment Status : Unknown
Verified April 2020 by Giancarlo Ceccarelli, University of Roma La Sapienza.
Recruitment status was: Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : May 4, 2020
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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.
Condition or disease | Intervention/treatment |
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COVID Pneumonia Diarrhea | Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine |
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 : | Observational |
Actual Enrollment : | 70 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19 |
Actual Study Start Date : | March 1, 2020 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | July 31, 2020 |

Group/Cohort | Intervention/treatment |
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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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Drug: Azithromycin
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) Drug: hydroxychloroquine 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.
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Dietary Supplement: SivoMixx (200 billion)
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) Drug: Azithromycin 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) Drug: hydroxychloroquine dose: 200 mg, 1 cp x 2 / day |
- delta of time of disappearance of acute diarrhea [ Time Frame: 21 days ]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.
- Delta in the number of patients requiring orotracheal intubation despite treatment [ Time Frame: 21 days ]Comparison between the two groups
- Delta of crude mortality [ Time Frame: 21 days ]Comparison between the two groups
- Delta of length of stay for patients in hospital [ Time Frame: 21 days ]Comparison between the two groups

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- COVID-19 diagnosis
- symptomatic COVID-19
- hospitalization in infectious diseases wards
Exclusion Criteria:
- Pregnant
- hospitalization in Intensive Care Unit

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368351
Italy | |
Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy) | |
Rome, Italy, 00161 |
Principal Investigator: | Gabriella d'Ettorre, MD, PhD | University of Rome Sapienza - Policlinico Umberto I Rome (Italy) |
Responsible Party: | Giancarlo Ceccarelli, MD, PhD, MSc, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT04368351 |
Other Study ID Numbers: |
DPHID-UniRoma05 |
First Posted: | April 29, 2020 Key Record Dates |
Last Update Posted: | May 4, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 pneumonia gut-lung axis microbiome |
COVID-19 Pneumonia Diarrhea Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Signs and Symptoms, Digestive Azithromycin Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |