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
| Registry | NCT04517422 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, other |
| Enrollment | 300 (Actual) |
| Sponsor | AB Biotics, SA (Industry); collaborators: Innovacion y Desarrollo de Estrategias en Salud, Hospital General Dr. Manuel Gea González, Hospital Angeles del Pedregal |
| Conditions | SARS-CoV Infection |
| Interventions | Probiotics, Placebo (Dietary supplement, other) |
| Dates | start 2020-08-19, primary completion 2021-02-02, completion 2021-02-02, first posted 2020-08-18, last updated 2021-05-06 |
| Locations | 1 site in Mexico |
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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.
Randomized controlled trial (RCT) to evaluate safety and efficacy of Lactobacillus plantarum CECT 30292, 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 30292, 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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotics | Active test product contains four lactic acid bacteria strains with Qualified Presumption of Safety (QPS)status by European Food Safety Authority (EFSA): Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, with maltodextrin (E1400, qs) as excipient, formulated in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0. Active test product is a food supplement and not an investigational medicinal product |
| Placebo | Placebo comparator | Other: Placebo | The control study product is identical in packaging and formulation except that Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483 (probiotic bacteria) are not present. The Control product only contains maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0. |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * Women or men, >18y to 60 years * RTq-PCR to COVID positive * Presence of cough, fever, dyspnoea, or headache, onset <= 7 days * Mild severity of COVID-19 * Peripheral Oxygen Saturation (SpO2) >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)
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital General Dr. Manuel Gea Gonzalez | Mexico City | Mexico |