Official Title
Efficacy and Safety of Lactobacillus Plantarum and Pediococcus Acidilactici as Co-adjuvant Therapy for Reducing the Risk of Severe Disease in Adults With SARS-CoV-2 and Its Modulation of the Fecal Microbiota: A Randomized Clinical Trial
Brief Summary

Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to progress to moderate or severe COVID and associated advantages such as reduce the risk of death. Adittionnally this RCT is launching to explore the benefits of this combination of strains to modulate fecal microbiome and explore how this correlate with clinical improvement.

Detailed Description

Randomized controlled trial (RCT) to evaluate safety and efficacy of Lactobacillus plantarum

CECT 7481, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485 y P.

acidilactici CECT 7483, one dose a day to reduce the risk of subjects with mild COVID-19 to

evolute to moderate or severe disease. As secondary aims this trial is intented to evaluate

the effect of this strains combinations to reduce the frequency and severity of

gastrointestinal COVID-19 symptoms and lung abnormalities, to reduce the viral load, modulate

the levels of IgG/IgM, and positively modify the fecal microbiota.



300 adults, 18 to 60 years, RTq-PCR positive for SARS-CoV-2, with mild COVID-19, and SpO2 >

90%, living in Mexico city (2,200m over the sea level) will be randomized, after sign of

informed consent to receive a combintation of Lactobacillus plantarum CECT 7481,

Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485 y P. acidilactici CECT

7483 one a day orally or placebo for 30 days.



Clinical severity, lung abnormalities (x-rays), viral load, IgG/IgM levels, and fecal

microbiome will be evaluated at COVID-19 research center before randomization. Participants

will be invited to remain at home and clinical evolution, temperature, SpO2 will be recorder

and reported remotely during the 30 days intervention.



On days 15 and 30, participants will be invited to return to COVID-19 research center to take

samples to evaluate evolution of viral load, IgG/IgM and fecal microbiome.



During the 30-days intervention period outcomes such as clinical progression, need of

hospitalization, admission to Intensive Care Unit and death will be evaluated

Active, not recruiting
SARS-CoV Infection

Dietary Supplement: Probiotics
Combination of Lactobacillus plantarum CECT7481, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483
Probiotics

Other: Placebo
Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0
Placebo

Eligibility Criteria

Inclusion Criteria: - Women or men, >18y to 60 years - RTq-PCR to COVID positive - Presence of cough, fever, dyspnoea, or headache, onset 90% - Able to read, understand and sign the informed consent - To have at least one family member to collaborate with the follow-up in the clinical findings at beginning and throughout of the study.

Exclusion Criteria: - Severe Obesity (BMI>40) - Uncontrolled Type II diabetes (HbA1C >8.0) - Uncontrolled systolic hypertension (>160mmdeHg) - Acute pancreatitis - Chronic diarrhea or constipation - Inflammatory bowel disease - Blood clotting disease - Immunosuppression derived from Cancer, post-transplantation, auto-immune disease or HIV - Severe and active seasonal allergies - Pregnancy or lactation - Glucose 6P-dehydrogenase deficiency - Regular use of probiotic or antibiotic within 2 weeks before entering the trial - Severe or uncontrolled Chronic Respiratory Diseases (Asthma, COPD or Cystic Fibrosis)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 60 Years
Countries
Mexico
AB Biotics, SA
Innovacion y Desarrollo de Estrategias en Salud
Hospital General Dr. Manuel Gea González
Hospital Angeles del Pedregal
NCT Number
Keywords
probiotics
SARS-CoV-2
Covid-19
Adults
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome