Probiotic improves symptomatic and viral clearance in Covid19 outpatients: a randomized, quadruple-blinded, placebo-controlled trial
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SciScore for 10.1101/2021.05.20.21256954: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial complied with the Declaration of Helsinki and applicable local regulations and was approved by the Research Ethics Committee of Hospital General Dr. Manuel Gea Conzalez of Mexico City (approval number 12-120-2020, ClinicalTrials.gov identifier: NCT04517422).
Consent: All participants provided written informed consent before entering the study.Sex as a biological variable Finally, exploratory, non-prespecified (post-hoc) endpoints included: i) significance of the primary endpoint when splitting the population according to age (less than 50 years old vs 50 years and older), sex (male vs female), metabolic comorbidity (diabetes, hypertension or obesity vs none), viral load at … SciScore for 10.1101/2021.05.20.21256954: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial complied with the Declaration of Helsinki and applicable local regulations and was approved by the Research Ethics Committee of Hospital General Dr. Manuel Gea Conzalez of Mexico City (approval number 12-120-2020, ClinicalTrials.gov identifier: NCT04517422).
Consent: All participants provided written informed consent before entering the study.Sex as a biological variable Finally, exploratory, non-prespecified (post-hoc) endpoints included: i) significance of the primary endpoint when splitting the population according to age (less than 50 years old vs 50 years and older), sex (male vs female), metabolic comorbidity (diabetes, hypertension or obesity vs none), viral load at baseline (below vs above median value at baseline) and time from symptom onset (one to four days vs five or more days); ii) time to symptomatic resolution, defined as the disappearance of all five core Covid19 symptoms according to patient diaries (fever, headache, cough, body aches and shortness of breath); and iii) number of days of use of acetaminophen, of loss of taste (ageusia) and of loss of smell (anosmia). Randomization Study Design: Randomized, quadruple-blinded (patient, caregiver, investigator and outcomes assessors), randomized, placebo-controlled, parallel-arms clinical trial, in outpatient subjects with recently diagnosed Covid19. Blinding Study products (active or placebo) were given in coded, anonymous boxes, and subjects, caregivers, investigators and outcome assessors were unaware of the treatment allocation. Power Analysis Taking the average value (47%) and aiming at detecting a relative reduction of at least 35% with a two-sided alpha = 5% and power = 80% resulted in 150 subjects per study arm after rounding up. Table 2: Resources
Software and Algorithms Sentences Resources All statistical analyses were performed with the SPSS program v.24 (IBS Corp., Armonk, US). SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:This study has several limitations worth mentioning. First, no patients older than 60 years old were included in the study. However, the consistency of the effect across age subpopulations when splitting the study sample at the 50 years-old cutoff suggests the effects of this probiotic are not limited to young adults, but additional studies in older populations are warranted. Second, all subjects in the study were of Hispanic ethnicity, which has been associated to higher mortality in Covid19. 32 In our study, reduction of viral load in placebo group was slower than reported in similar studies where Hispanic subjects accounted for 50% or less of the study population. 18,19 Accordingly, our study population could be regarded as more challenging, but replication studies should be performed in more diverse populations. Third, the 16S stool microbiome analysis is still ongoing at the time of writing. Microbiome analysis could provide clues about the mechanism of action of the probiotic formula used in this trial and/or reveal if baseline enterotype influences the effectiveness of the probiotic. However, microbiome changes are not required for a probiotic to be effective since activity could be due to crosstalk between the probiotic strains per se and the host’s immune system. Results of microbiome analysis and digestive symptoms will be jointly reported in future publications. Fourth, the SARS-CoV2 strains affecting patients in this study were not determined. In our view, this st...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04517422 Completed Efficacy of L. Plantarum and P. Acidilactici in Adults With … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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