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. 2022 Aug 12;13:963488. doi: 10.3389/fmicb.2022.963488

TABLE 3.

Several clinical studies of microecological intervention in COVID-19.

Identifier Recruiting status Study subjects Age Country Sample size Supplement Intervention Primary outcome Access link
NCT04390477 Completed Patients with a confirmed diagnosis of SARS-CoV-2 and require admission to the hospitalization ≥18 years Spain 41 Probiotic 1 pill containing probiotic 1 × 109 CFU or Placebo. 1 oral capsule per day for 30 days. Percentage of patients with discharge to ICU https://clinicaltrials.gov/ct2/show/NCT04390477
NCT04458519 Completed COVID-19 patients not requiring hospitalization 18−59 years Canada 23 Probiotic Nasal irrigations with Probiorinse 2.4 Billion CFU (Colony-Forming Units) of Lactococcus Lactis W136 or saline (NeilMed Sinus Rinse). Twice-daily for a period of 14 days Change in severity of COVID-19 infection https://clinicaltrials.gov/ct2/show/NCT04458519
NCT04507867 Completed Stage III positive COVID-19 patients with comorbidities (type 2 DM, SAH, overweight/obesity with BMI < 35) 30−75 years Mexico 80 Synbiotic Combination of three B vitamins (B1, B6, and B12) “Neurobion” 10 mg solution for IM injection, One every 24 h for the first 5 days. Probiotics Saccharomyces boulardii CNCM I-745 “Floratil.” One morning and one evening 250 mg capsule during the first 6 days. One envelope of NSS-1 in the morning and one envelope in the afternoon mixed with 400 ml of water each, contain nutritional support system or placebo Overall mortality at day 40 and overall survival https://clinicaltrials.gov/ct2/show/study/NCT04507867
NCT04517422 Completed Mild COVID-19 patients, cough, fever, dyspnoea, or headache, onset < = 7 days 18−60 years Mexico 200 Probiotic Probiotics (Lactiplantibacillus plantarum CECT30292, Lactiplantibacillus plantarum CECT 7484, Lactiplantibacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483) or Placebo (maltodextrin). Oral for 30 days Severity of COVID-19 progression; stay of patients at ICU and mortality ratio https://clinicaltrials.gov/ct2/show/NCT04517422
NCT04621071 Completed COVID-19 patients ≥18 years Canada 17 Probiotic Dietary Supplement: Probiotics (2 strains 10 × 109 UFC) or Placebo (potato starch and magnesium stearate). From Day 1 to Day 10 two capsules a day, Day 11 to Day 25 one capsule a day, maximum of 25 days, if they are admitted to the hospital treatment will stop Duration of symptoms of the COVID-19 https://clinicaltrials.gov/ct2/show/NCT04621071
NCT04734886 Completed Previous diagnosis of COVID-19 (by positive PCR) or previous confirmation of seropositivity to SARS-CoV-2 18−60 years Sweden 161 Probiotic Dietary Supplement: L. reuteri DSM 17938 + vitamin D or Placebo + vitamin D. Two capsules per day for 6 months SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms https://clinicaltrials.gov/ct2/show/NCT04734886
NCT04824222 Not yet recruiting COVID-19 patients with expected survival time, not taking into account SARS-CoV-2 infection, is at least 6 months. Hospitalization due to COVID 19 disease or disease with accompanied COVID 19. ≥18 years Not provided 366 Fecal microbiota transplantation (FMT) FMT be administered in double cover, gastro-resistant, enteric release capsules in 60 g dose or placebo Incidence of adverse events after administration of IMP in the phase II/III, percentage of patients requiring escalation of oxygen therapy in non-invasive and invasive methods in phase III https://clinicaltrials.gov/ct2/show/NCT04824222
NCT04847349 Completed SARS-CoV-2 infection > 4 months prior confirmed 18−60 years United States 54 Probiotic Probiotic consortium OL-1, standard dose or Probiotic consortium OL-1, high dose or Placebo (potato starch, maltodextrin). A capsule once per day with breakfast for 21 days Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG) https://clinicaltrials.gov/ct2/show/NCT04847349
NCT04854941 Completed COVID-19 patients 18−75 years Russian Federation 200 Probiotic Probiotics (109 CFU of each strain: Lactobacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911 and Bifidobacterium longum PDV 2301) or standard regimen for COVID-19. Three times a day during the hospital stay but for no more than 14 days, the end point was day 14 or patient’s discharge or death The number of died patients during hospitalization https://clinicaltrials.gov/ct2/show/NCT04854941
NCT05043376 Completed Hospitalized confirmed (RT-PCR) COVID-19 patients not receiving mechanical ventilatory support ≥18 years Pakistan 50 Probiotic Dietary Supplement: BLIS K12 (Streptococcus salivarius K12). Daily 2 oral BLIS K12 tablets for up to 14 days Recovery and live discharge, number of patients with clinical improvement https://clinicaltrials.gov/ct2/show/NCT05043376
NCT05175833 Completed patients hospitalized in the ICU with severe acute respiratory syndrome ≥18 years Brazil 70 Probiotic Oral gel containing streptococcus salivarius K12 and lactobacillus brevis CD2 or containing placebo The oral gel was applied in the mouth every 8 h for 7 days The occurrence of symptoms and signs of secondary bacterial pneumonia https://clinicaltrials.gov/ct2/show/NCT05175833
IRCT20080826001096N8 Recruiting Pregnant women with mild/moderate COVID-19 ≥16 years Iran 80 Synbiotic Lactofem capsule, contains 500 mg of 4 strains of probiotic lactobacilli including Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fermentum, Lactobacillus gasseri and 38.5 mg of prebiotic substances including fructooligosaccharides or placebo Twice daily after meals for at least 7 days until hospitalization Duration from the start of the study until the improvement of clinical symptoms. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20080826001096N8
IRCT20200117046164N2 Recruiting Asthmatic children without positive history of COVID-19 6−18 years Iran 90 Probiotic Probiotic nasal spray contains Lactobacillus reuteri and Lactobacillus casei or rhinosaline nasal spray Administer twice daily, one puff in each nostril, for 1 month Abnormality in smell, Axillary temperature above 38 Celsius degree, Development of respiratory and gasterointestinal symptoms https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20200117046164N2
ChiCTR2000029999 Prospective registration COVID-19 patients ≥18 years China 60 Probiotic Specific probiotic types not yet available Several parameters associated to gut microbiome, fecal metabolomics, cytokines, biochemical, hematological, imageology, etc. https://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR2000029999