Table 3.
Ongoing registered trials studying role of gut microbiota in COVID-19 (updated as of June 19, 2021).
| A. Ongoing observational studies | ||
|---|---|---|
| Trial number | Title | Summary |
| NCT04669938 | Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease, COVID-19, in Hospitalized Patients | Observational study looking at the effect of oropharyngeal and gut microbiota, host genotype, and immune characteristics and SARS-CoV-2 viral genome sequences on outcomes of COVID-19 infection. |
| NCT04598334 | Cytokine Storm Among Bangladeshi Patients With COVID-19 | Prospective study evaluating the relationship of inflammatory markers and cytokine levels in addition to gut microbiota on COVID-19 infection severity in Bangladeshi patients, at various points of illness progression. |
| NCT04597736 | Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) | Cohort study examining the relationship between the biological profiles observed from analysis of nasopharyngeal, saliva, blood, stool, and urine samples and the clinical evolutions within the same cluster of COVID-19 cases and their contact subjects. |
| NCT04581135 | Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19 | Prospective study investigating long-term pulmonary and extrapulmonary effects of COVID-19, including changes to gut microbiota. |
| NCT04552340 | Epidemiologic, Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV | Observational study examining factors including alveolar and nasal microbiota on predisposition to SARS-CoV2 viral infection, symptomology, treatment response, and predisposition to complications. |
| NCT04497402 | Sex-Informed Data in the COVID-19 Pandemic | Observational study looking at differences in the biomarkers of different sexes during SARS-CoV-2 infection, including the gut microbiome. |
| NCT04475211 | Predictors of Mortality at Day 28 of Patients Treated at Lille University Hospital for COVID-19 | Retrospective observational study to evaluate predictive factors of mortality at day 28 in COVID-19 patients treated at a single center. |
| NCT04451577 | Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without COVID-19 Infection | Case–control study evaluating biological samples obtained from hospital employees to characterize SARS-CoV-2 pathogenesis and individual differences in susceptibility to the disease. |
| NCT04410263 | Microbiota in COVID-19 Patients for Future Therapeutic and Preventive Approaches | Observational study analyzing biological samples including nasopharyngeal and alveolar microbiota to elucidate risk factors for the development of severe ARDS in SARS-CoV-2 infected patients. |
| NCT04359836 | A Study to Explore the Role of Gut Flora in COVID-19 Infection | Observational study aiming to sequence and characterize the gut microbiome of COVID-19 patients during and after treatment. |
| NCT04359706 | Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19 | Observational study comparing the respiratory and gut microbiota and inflammatory markers of critically ill COVID-19 patients with historical critically ill patients without COVID-19. |
| NCT04355741 | Gut Microbiota, “Spark and Flame” of COVID-19 Disease | Observational study analyzing and comparing the gut microbiome of COVID patients across settings in the intensive care unit, hospital general ward, and self-caring at home. |
| NCT04332016 | COVID-19 Biological Samples Collection | Observational collection and analysis of biological samples including gut microbiota of patients with COVID-19 infection and their caregivers. |
| NCT04325919 | Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong | Observational study characterizing clinical, virological, microbiological, and immunological profiles of COVID-19 infection compared against patients hospitalized for pneumonia. |
| NCT04708912 | Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19) | Observational study comparing nasopharynx microbiota composition, RNA sequences, and in vitro cytokine production in COVID-19 patients with mild-moderate, severe, convalescent disease and healthy controls. |
| NCT04768244 | Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health (MilkCorona) | Prospective study assessing the impact of maternal COVID-19 on immune, microbiological, and metabolic profile of breast milk and infant microbiota, growth, and development. |
| NCT04913142 | About Oral and Gut Microbiota in Intensive Care Unit: SARS-CoV-2 (COVID-19) Infection Impact (CO-MIC) | Prospective cohort study to describe the impact of SARS-CoV-2 infection on the oral and gut microbiota of ICU patients, and to compare against the microbiota of non-COVID-19 ICU patients. |
| NCT04813328 | A Pilot Study of the Effects of Helminth Infection and SARS-CoV-2 Seropositivity on Immune Response and the Intestinal Microbiota in India | Cross-sectional study to characterize the immune response and intestinal microbiota in people with and without SARS-CoV-2 antibodies and helminth infection. |
| B. Ongoing studies utilizing microbiota as therapeutic target | ||
| Trial number | Title | Summary |
| NCT04666116 | Changes in Viral Load in COVID-19 After Probiotics | Randomized clinical trial evaluating the capacity of a novel nutritional supplement intervention in decreasing SARS-CoV-2 viral load by nasopharyngeal swab |
| NCT04621071 | Efficacy of Probiotics in Reducing Duration and Symptoms of COVID-19 | Randomized controlled trial to evaluate the efficacy of probiotics in reducing the duration and symptoms of COVID-19 in a symptomatic population tested positive to SARS-CoV-2, self-caring at home |
| NCT04581018 | An Evaluation of a Synbiotic Formula for Patients With COVID-19 Infection | Non-randomized clinical trial examining effect of a synbiotic health supplement on COVID-19 symptoms |
| NCT04517422 | Efficacy of L. Plantarum and P. acidilactici in Adults With SARS-CoV-2 and COVID-19 | Randomized controlled trial to study ability of a probiotic to reduce progression of mild COVID-19 infection to moderate/severe disease and other prognostic factors, including gastrointestinal symptoms and gut microbiome composition |
| NCT04486482 | A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function | Randomized trial evaluating effects of a novel glycan on the gut microbiota of outpatients with COVID-19. |
| NCT04479202 | The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With COVID-19 | Double-blinded randomized trial analyzing the effect of berberine on gut microbiota, gastrointestinal manifestations, and inflammatory markets in patients with severe COVID-19. |
| NCT04420676 | Synbiotic Therapy of Gastrointestinal Symptoms During COVID-19 Infection | Clinical trial comparing a probiotic mixture to placebo in alleviating gastrointestinal symptoms and altering gut microbiome in COVID-19 infection. |
| NCT04399252 | Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19 | Randomized trial assessing the effect of Lactobacillus rhamnosus GG on the microbiome of household contacts of COVID-19 patients. |
| NCT04540406 | NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients (COVGUT20) | Open-label, randomized controlled trial assessing the feasibility and effectiveness of a novel botanical-based fixed-combination drug to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients. |
| NCT04390477 | Study to Evaluate the Effect of a Probiotic in COVID-19 | Prospective case–control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2 |
| NCT04366089 | Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora (PROBIOZOVID) | Randomized trial evaluating the adjuvant use of oxygen ozone therapy plus probiotic supplementation in addition to standard of care in the early control of disease progression in patients with COVID-19. |
| NCT04877704 | Symprove (Probiotic) as an add-on to COVID-19 Management | Randomized trial studying outcomes in COVID-19 patients treated with adjunctive probiotics for 3 months. A sub-study, subject to participant consent, will also collect biological samples for comparative analysis. |
| NCT04734886 | The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19 | Randomized trial assessing the impact of L. reuteri DSM 17938 on SARS-CoV-2-specific antibody response upon and after infection in healthy adults, in addition to inflammatory markers, symptom severity and duration. |
| NCT04390477 | The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection | Pilot study on the effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with SARS-CoV-2. |
| NCT04366180 | Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19 | Randomized controlled trial evaluating the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of COVID-19 in health workers exposed to the SARS-CoV-2 virus. |
| NCT04907877 | Role of Nutritional Support With Probiotics in Adult Outpatients With Symptomatic COVID-19: a Randomized Dietary Study | Randomized controlled trial comparing the effect of a probiotic mixture of bifido- and lactobacteria on COVID-19 severity and subsequent immune response. |
| NCT04854941 | Efficacy of Probiotics (Lactobacillus Rhamnosus, Bifidobacterium Bifidum, Bifidobacterium Longum Subsp. Infantis and Bifidobacterium Longum) in the Treatment of Hospitalised Patients With Novel Coronavirus Infection | Randomized controlled open-label study analyzing the effect of a probiotic mixture consisting of L. rhamnosus, B. bifidum, B, longum subsp. infantis and B. longum on SARS-Cov-2 infection outcomes. |
| NCT04798677 | Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine | Randomized, single-center trial comparing the immune response of volunteers who had nutritional supplementation with a probiotic formulation while receiving the influenza or COVID-19 vaccine. |
| NCT04847349 | Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial) | Pilot study on the efficacy of a combination of live probiotics on antibody titers, symptom improvement and reinfection risk in unvaccinated persons previously infected with SARS-CoV-2. |
| NCT04756466 | Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly | Multi-center randomized controlled trial evaluating the effect of a probiotic strain on the incidence and severity of COVID-19, as well as the immune response to COVID-19 vaccination, in an elderly population living in a nursing home. |
| NCT04922918 | Administration of Ligilactobacillus salivarius MP101 in an Elderly Nursing Home During the COVID Pandemics | Clinical trial investigating the effect of Ligilactobacillus salivarius MP101 on the functional, cognitive, and nutritional status, as well as nasal and fecal inflammatory profiles of elderly people living in a nursing home highly affected by COVID-19. |
| NCT04793997 | Covid-19 Primary Care Support With Microbiome Therapy | Randomized controlled trial evaluating the efficacy of a probiotic throat spray in reducing symptoms COVID-19 in patients with mild to moderate symptoms. Secondary outcome of whether the spray can prevent transmission of the SARS-CoV-2 virus to household members. |
| NCT04884776 | Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic | Randomized controlled trial studying a probiotic formula in enhancing immunity and reducing hospitalization in elderly and diabetic patients. |
| NCT04824222 | The Impact of Fecal Microbiota Transplantation as an Immunomodulation on the Risk Reduction of COVID-19 Disease Progression With Escalating Cytokine Storm and Inflammatory Parameters (FeMToCOVID) | Randomized phase II (open-label) and phase III (double-blinded) trial evaluating the effect of fecal microbiota transplantation (FMT) as an immunomodulator in addition to standard therapy on the risk reduction of disease progression in COVID-19 with escalating cytokine storm and inflammatory markers. |
Extracted from the database of clinicaltrials.org on June 19, 2021.