NCT04368351: BACT-ovid

Bacteriotherapy in the Treatment of COVID-19

Status unknown Last updated 4 May 2020

What this trial tests

trial testing SivoMixx (200 billion) in COVID in 70 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
30 June 2020

31 July 2020

Quick facts

Lead sponsor	University of Roma La Sapienza
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	70
Start date	1 March 2020
Primary completion	30 June 2020
Estimated completion	31 July 2020
Sites	1 location across Italy

Drugs / interventions tested

• SivoMixx (200 billion)
• Azithromycin (azithromycin) — full drug profile →
• hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →

Conditions studied

• COVID — all drugs for COVID →
• Pneumonia — all drugs for Pneumonia →
• Diarrhea — all drugs for Diarrhea →

Sponsor

University of Roma La Sapienza

Who can join

18 and older, any sex, with COVID or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ACE2 imbalance as a key player for the poor outcomes in COVID-19 patients with age-related comorbidities - Role of gut microbiota dysbiosis.
   Viana SD, Nunes S, Reis F. · · 2020 · cited 122× · PMID 32683039 · DOI 10.1016/j.arr.2020.101123
2. Diet Supplementation, Probiotics, and Nutraceuticals in SARS-CoV-2 Infection: A Scoping Review.
   Infusino F, Marazzato M, Mancone M, Fedele F, et al · · 2020 · cited 119× · PMID 32521760 · DOI 10.3390/nu12061718
3. Key Aspects in Nutritional Management of COVID-19 Patients.
   Fernández-Quintela A, Milton-Laskibar I, Trepiana J, Gómez-Zorita S, et al · · 2020 · cited 70× · PMID 32785121 · DOI 10.3390/jcm9082589
4. SARS-CoV-2 microbiome dysbiosis linked disorders and possible probiotics role.
   Din AU, Mazhar M, Waseem M, Ahmad W, et al · · 2021 · cited 65× · PMID 33197765 · DOI 10.1016/j.biopha.2020.110947
5. Review article: Probiotics, prebiotics and dietary approaches during COVID-19 pandemic.
   Hu J, Zhang L, Lin W, Tang W, et al · · 2021 · cited 62× · PMID 33519087 · DOI 10.1016/j.tifs.2020.12.009
6. Widely available lysosome targeting agents should be considered as potential therapy for COVID-19.
   Homolak J, Kodvanj I. · · 2020 · cited 54× · PMID 32522674 · DOI 10.1016/j.ijantimicag.2020.106044
7. Potential contribution of beneficial microbes to face the COVID-19 pandemic.
   Antunes AEC, Vinderola G, Xavier-Santos D, Sivieri K. · · 2020 · cited 49× · PMID 32846611 · DOI 10.1016/j.foodres.2020.109577
8. Gut Microbiota Dysbiosis-Immune Hyperresponse-Inflammation Triad in Coronavirus Disease 2019 (COVID-19): Impact of Pharmacological and Nutraceutical Approaches.
   Ferreira C, Viana SD, Reis F. · · 2020 · cited 44× · PMID 33019592 · DOI 10.3390/microorganisms8101514