Clinical trial NCT04368351: Bacteriotherapy in the Treatment of COVID-19
Official title: Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Pneumonia
Diarrhea
Keywords: COVID-19 pneumonia
gut-lung axis
microbiome
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic patients affected by COVID-19 admitted to Policlinico Umberto I, University of Rome "Sapienza" (Italy), between March 14, 2020 and April 4, 2020.

Brief summary: 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.

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 .

Eligibility criteria: Inclusion Criteria:

* COVID-19 diagnosis
* symptomatic COVID-19
* hospitalization in infectious diseases wards

Exclusion Criteria:

* Pregnant
* hospitalization in Intensive Care Unit

Primary outcomes:
measure: delta of time of disappearance of acute diarrhea
timeFrame: 21 days
Secondary outcomes:
measure: Delta in the number of patients requiring orotracheal intubation despite treatment
timeFrame: 21 days
measure: Delta of crude mortality
timeFrame: 21 days
measure: Delta of length of stay for patients in hospital
timeFrame: 21 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
Study officials:
affiliation: University of Rome Sapienza - Policlinico Umberto I Rome (Italy)
name: Gabriella d'Ettorre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.