Efficacy of L. Plantarum and P. Acidilactici in Adults With SARS-CoV-2 and COVID-19

May 2, 2021 updated by: AB Biotics, SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 14080
        • Hospital General Dr. Manuel Gea González

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: Probiotics
Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483
Placebo Comparator: 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.
Other: Placebo
Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity progression of COVID-19
Time Frame: 30 days
Frequency of randomized subjects who progress from mild to moderate or severe COVID-19, or remission, as evaluated by WHO Clinical Progression Scale
30 days
Stay at ICU
Time Frame: 30 days
Length of stay at Intensive Care Unit (ICU)
30 days
Mortality ratio
Time Frame: 30 days
Mortality ratio for all causes related to COVID-19
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load
Time Frame: 30 days
Description of SARS-Cov-2 viral load evaluated by RT-PCR at screening and on days 15 and 30
30 days
Lung abnormalities
Time Frame: 30 days
Frequency of lung abnormalities clasified by severity and measured by x-ray and artificial intelligence
30 days
Levels of immunoglobulins
Time Frame: 30 days
Levels of Immunoglobulin G and Immunoglobulin M evaluated on day 15 and 30
30 days
Gastrointestinal manifestations, where 0 means good health status and 5 worse status
Time Frame: 30 days
Frequency and severity of gastrointestinal manifestation evaluated by Gastrointestinal Symptom Rating Scale (GSRS)
30 days
Fecal microbiome
Time Frame: 30 days
Changes on fecal microbiome evaluated by 16S analysis on day 1st and 30th
30 days
Adverse events
Time Frame: 30 days
Frequency of adverse events reported on dairy report form after randomization and until day 30
30 days
Change on Serum Biomarkers
Time Frame: Days 1st, 15th and 30th after randomization
Change on high sensitivity C-reactive protein (hsCRP) and D-Dimer
Days 1st, 15th and 30th after randomization
Duration of Individual Symptoms
Time Frame: 30 days
Days of fever, cough, myalgia, dyspnea and headache
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Biotics, SA

Collaborators

Hospital General Dr. Manuel Gea González
Innovacion y Desarrollo de Estrategias en Salud
Hospital Angeles del Pedregal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 2, 2021

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 16, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABB-COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified individual patient data (IPD), together with data dictionary defining each field in the set, will be made public upon any formal requests with a defined analysis plan.

IPD Sharing Time Frame

From the moment of manuscript publication, without time limit.

IPD Sharing Access Criteria

Formal request with a defined analysis plan. Please contact espadaler@ab-biotics.com or medical@ab-biotics.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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