Status:
COMPLETED
Efficacy of L. Plantarum and P. Acidilactici in Adults With SARS-CoV-2 and COVID-19
Lead Sponsor:
AB Biotics, SA
Collaborating Sponsors:
Innovacion y Desarrollo de Estrategias en Salud
Hospital General Dr. Manuel Gea González
Conditions:
SARS-CoV Infection
Eligibility:
All Genders
18-60 years
Phase:
NA
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 objecti...
Detailed Description
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 748...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04517422
Start Date
August 19 2020
End Date
February 2 2021
Last Update
May 6 2021
Active Locations (1)
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1
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico, 14080