Probiotic improves symptomatic and viral clearance in Covid19 outpatients: a randomized, quadruple-blinded, placebo-controlled trial
et al., Gut Microbes, doi:10.1080/19490976.2021.2018899 (date from earlier preprint), NCT04517422 (history)
, Probiotic improves symptomatic and viral clearance in Covid19 outpatients: a randomized, quadruple-blinded,.., Gut Microbes, doi:10.1080/19490976.2021.2018899 (date from earlier preprint), NCT04517422
RCT 293 outpatients in Mexico, 147 treated with a probiotic composed of three L. plantarum strains (KABP022, KABP023 and KABP033) and one P. acidilacti strain (KABP021), showing improved recovery with treatment. There were no hospitalizations or deaths. NCT04517422 (history).The immune effects of probiotics are strain-specific.
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risk of no recovery, 34.7% lower, RR 0.65, p < 0.001, treatment 69 of 147 (46.9%), control 105 of 146 (71.9%), NNT 4.0.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Gutiérrez-Castrellón et al., 24 May 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Mexico, peer-reviewed, 9 authors, average treatment delay 4.0 days, trial NCT04517422 (history).
Abstract: Gut Microbes
ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/kgmi20
Probiotic improves symptomatic and viral
clearance in Covid19 outpatients: a randomized,
quadruple-blinded, placebo-controlled trial
Pedro Gutiérrez-Castrellón, Tania Gandara-Martí, Ana T. Abreu Y Abreu,
Cesar D. Nieto-Rufino, Eduardo López-Orduña, Irma Jiménez-Escobar, Carlos
Jiménez-Gutiérrez, Gabriel López-Velazquez & Jordi Espadaler-Mazo
To cite this article: Pedro Gutiérrez-Castrellón, Tania Gandara-Martí, Ana T. Abreu Y Abreu,
Cesar D. Nieto-Rufino, Eduardo López-Orduña, Irma Jiménez-Escobar, Carlos Jiménez-Gutiérrez,
Gabriel López-Velazquez & Jordi Espadaler-Mazo (2022) Probiotic improves symptomatic and viral
clearance in Covid19 outpatients: a randomized, quadruple-blinded, placebo-controlled trial, Gut
Microbes, 14:1, 2018899, DOI: 10.1080/19490976.2021.2018899
To link to this article: https://doi.org/10.1080/19490976.2021.2018899
© 2022 The Author(s). Published with
license by Taylor & Francis Group, LLC.
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Published online: 11 Jan 2022.
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GUT MICROBES
2022, VOL. 14, NO. 1, e2018899 (16 pages)
https://doi.org/10.1080/19490976.2021.2018899
RESEARCH PAPER
Probiotic improves symptomatic and viral clearance in Covid19 outpatients:
a randomized, quadruple-blinded, placebo-controlled trial
Pedro Gutiérrez-Castrellón a,b, Tania Gandara-Martía, Ana T. Abreu Y Abreuc, Cesar D. Nieto-Rufinoa,
Eduardo López-Orduñad, Irma Jiménez-Escobara, Carlos Jiménez-Gutiérreza, Gabriel López-Velazquezb,
and Jordi Espadaler-Mazo e
a
Centro de Investigación Translacional en Ciencias de la Salud, Hospital General Dr. Manuel Gea Gonzalez, Ciudad de México, (CDMX), México;
International Scientific Council for Probiotics, Ciudad de México, (CDMX), México; cDigestive Unit, Hospital Angeles Pedregal, Ciudad de
México, (CDMX), México; dDiagnoMol SA de CV, Ciudad de México (CDMX), México; eR&D Department, AB-Biotics SA (KANEKA Group) Sant
Cugat, (Barcelona) Spain
b
ABSTRACT
ARTICLE HISTORY
Intestinal bacteria may influence lung homeostasis via the gut-lung axis. We conducted a singlecenter, quadruple-blinded, randomized trial in adult symptomatic Coronavirus Disease 2019
(Covid19) outpatients. Subjects were allocated 1:1 to probiotic formula (strains Lactiplantibacillus
plantarum KABP022, KABP023, and KAPB033, plus strain Pediococcus acidilactici KABP021, totaling
2 × 109 colony-forming units (CFU)) or placebo, for 30 days. Co-primary endpoints included: i)
proportion of patients in complete symptomatic and viral remission; ii) proportion progressing to
moderate or severe disease with hospitalization, or death; and iii) days on Intensive Care Unit (ICU).
Three hundred subjects were randomized (median age 37.0 years [range 18 to 60], 161 [53.7%]
women, 126 [42.0%] having known metabolic risk factors), and 293 completed the study (97.7%).
Complete remission was achieved by 78 of 147 (53.1%) in probiotic group compared to 41 of 146
(28.1%) in placebo (RR: 1.89 [95 CI 1.40–2.55]; P < .001), significant after multiplicity correction. No
hospitalizations or deaths occurred during the study, precluding the assessment of remaining coprimary outcomes. Probiotic supplementation was well-tolerated and reduced..
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