Table 2.
Clinical trials with COVID-19 patients for the study of gut microbiota (Clinicaltrial.gov).
| Intervention/Main aims | Patients’ s conditions | Study type and nr participants* | Country | Trial ID and phase** |
|---|---|---|---|---|
| Changes in fecal microbiota composition | Hospitalized COVID-19 patients | Obs. / Prosp. 170 participants | Hong Kong |
NCT04325919 Phase: NA |
| Changes in respiratory and fecal microbiota composition | COVID-19 patients admitted to the ICU | Obs. / Prosp. 30 participants |
Not Provided |
NCT04359706 Phase: NA |
| Changes in fecal microbiota composition | COVID-19 patients: self-isolated at home; in an isolated hospital and in the ICU of the hospital |
Obs. / Prosp. 60 participants |
Portugal (MC) |
NCT04355741 Phase: NA |
| Probiotic supplementation - SivoMixx | Hospitalized COVID-19 patients | Interv. / Par. Ass. 152 participants |
Italy |
NCT04366089 Phase 2 |
| Changes in fecal microbiota composition | Hospitalized COVID-19 patients | Obs. / Prosp. 2000 participants |
France |
NCT04332016 Phase: NA0 |
| Correlation of immune profiling with microbiome analysis | Hospitalized COVID-19 patients | Obs. / Prosp. 100 participants |
Not provided |
NCT04327570 Phase: NA |
| Probiotic supplementation | Hospitalized COVID-19 patients | Interv. / Par. Ass. 40 participants |
Spain |
NCT04390477 Phase: NA |
| Probiotic supplementation – SivoMixx + Azithromycin | Hospitalized COVID-19 patients | Obs. / Retros. 70 participants |
Italy |
NCT04368351 Phase: NA |
| Correlation of feces microbiome and clinical outcome for COVID-19 | COVID-19 patients | Obs. / Prosp. 150 participants |
Not provided |
NCT04359459 Phase: NA |
| Correlation between oral microbiome and COVID-19 infection status | Asymptomatic COVID-19 patients | Obs. / Prosp. 500 participants |
Not provided |
NCT04345510 Phase: NA |
| Supplementation with natural polyphenols-Tannins | Hospitalized COVID-19 patients | Interv. / Par. Ass. 140 participants |
Not provided |
NCT04403646 Phase: NA |
| Changes in fecal microbiota composition | COVID-19 patients | Obs. 250 participants |
United States |
NCT04359836 Phase: NA |
| Probiotic supplementation - Omnibiotic ® AAD | COVID-19 patients with pre-existing diarrhoea | Interv. / Par. Ass. 108 participants |
Austria |
NCT04420676 Phase: NA |
| Correlation of gut microbiome to disease | COVID-19 patients | Obs. 250 participants |
United States |
NCT04359836 Phase: NA |
COVID-19, Coronavirus disease; ICU, intensive care unit; Interv., interventional; MC, multicentre study; NA, not applicable; Obs., observational; Par. Ass., parallel assignment; Prosp., prospective.
*
Estimated number of total participants.
**
FDA definitions of clinical trial phases.