Efficacy of a Probiotic Consisting of Lacticaseibacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911, and Bifidobacterium longum subsp. longum PDV 2301 in the Treatment of Hospitalized Patients with COVID-19: a Randomized Controlled Trial
Ivashkin et al.
, Efficacy of a Probiotic Consisting of Lacticaseibacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903,..
, Probiotics Antimicrob Proteins, doi:10.1007/s12602-021-09858-5, NCT04854941
RCT 200 patients, 99 treated with a probiotic (Lacticaseibacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911, and Bifidobacterium longum subsp. longum PDV 2301). There was no significant difference in mortality or recovery time, however benefits were seen for diarrhea. NCT04854941 (history)
The immune effects of probiotics are strain-specific.
risk of death, 2.0% higher, RR 1.02, p = 1.00, treatment 4 of 99 (4.0%), control 4 of 101 (4.0%).
risk of mechanical ventilation, 18.4% lower, RR 0.82, p = 1.00, treatment 4 of 99 (4.0%), control 5 of 101 (5.0%), NNT 110.
risk of ICU admission, 27.1% lower, RR 0.73, p = 0.77, treatment 5 of 99 (5.1%), control 7 of 101 (6.9%), NNT 53.
recovery time, 4.8% lower, relative time 0.95, p = 0.47, treatment 99, control 101.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ivashkin et al., 13 Oct 2021, Randomized Controlled Trial, Russia, peer-reviewed, 11 authors, average treatment delay 8.0 days, trial NCT04854941 (history)
Abstract: Probiotics and Antimicrobial Proteins
Efficacy of a Probiotic Consisting of Lacticaseibacillus rhamnosus PDV
1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum
subsp. infantis PDV 1911, and Bifidobacterium longum subsp. longum
PDV 2301 in the Treatment of Hospitalized Patients with COVID‑19:
a Randomized Controlled Trial
Vladimir Ivashkin1,2 · Victor Fomin1 · Sergey Moiseev1 · Michail Brovko1 · Roman Maslennikov1,2 ·
Anatoly Ulyanin1,2 · Victoria Sholomova1 · Maria Vasilyeva1 · Elizaveta Trush1 · Oleg Shifrin1 · Elena Poluektova1,2
Accepted: 5 October 2021
© The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2021
The treatment of coronavirus disease (COVID-19) and COVID-19-associated diarrhea remains challenging. This study aimed
to evaluate the efficacy of a multi-strain probiotic in the treatment of COVID-19. This was a randomized, controlled, singlecenter, open-label trial (NCT04854941). Inpatients with confirmed COVID-19 and pneumonia were randomly assigned to a
group that received a multi-strain probiotic (PRO group) or to the control group (CON group). There were 99 and 101 patients
in the PRO and CON groups, respectively. No significant differences in mortality, total duration of disease and hospital stay,
incidence of intensive care unit admission, need for mechanical ventilation or oxygen support, liver injury development, and
changes in inflammatory biomarker levels were observed between the PRO and CON groups among all included patients as
well as among subgroups delineated based on age younger or older than 65 years, and subgroups with chronic cardiovascular
diseases and diabetes. Diarrhea on admission was observed in 11.5% of patients; it resolved earlier in the PRO group than
in the CON group (2 [1–4] vs. 4 [3–6] days; p = 0.049). Hospital-acquired diarrhea developed less frequently in the PRO
group than in the CON group among patients who received a single antibiotic (0% vs. 12.5%; p = 0.023) unlike among those
who received > 1 antibiotic (10.5% vs. 13.3%; p = 0.696). The studied probiotic had no significant effect on mortality and
changes in most biomarkers in COVID-19. However, it was effective in treating diarrhea associated with COVID-19 and in
preventing hospital-acquired diarrhea in patients who received a single antibiotic.
Keywords COVID-19 · Probiotics · Diarrhea · Mortality · Liver
is less effective
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