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

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ClinicalTrials.gov Identifier: NCT04517422
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : May 6, 2021
Sponsor:
Collaborators:
Innovacion y Desarrollo de Estrategias en Salud
Hospital General Dr. Manuel Gea González
Hospital Angeles del Pedregal
Information provided by (Responsible Party):
AB Biotics, SA

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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Dietary Supplement: Probiotics Other: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trials. 300 subjects (18-60 years old) will be allocated to receive a combination of Lactobacillus plantarum CECT 30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and P. acidilactici CECT 7483 (branch one) or placebo (branch two)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator
Primary Purpose: Other
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
Actual Study Start Date : August 19, 2020
Actual Primary Completion Date : February 2, 2021
Actual Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. Stay at ICU [ Time Frame: 30 days ]
    Length of stay at Intensive Care Unit (ICU)

  3. Mortality ratio [ Time Frame: 30 days ]
    Mortality ratio for all causes related to COVID-19


Secondary Outcome Measures :
  1. 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

  2. Lung abnormalities [ Time Frame: 30 days ]
    Frequency of lung abnormalities clasified by severity and measured by x-ray and artificial intelligence

  3. Levels of immunoglobulins [ Time Frame: 30 days ]
    Levels of Immunoglobulin G and Immunoglobulin M evaluated on day 15 and 30

  4. 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)

  5. Fecal microbiome [ Time Frame: 30 days ]
    Changes on fecal microbiome evaluated by 16S analysis on day 1st and 30th

  6. Adverse events [ Time Frame: 30 days ]
    Frequency of adverse events reported on dairy report form after randomization and until day 30

  7. Change on Serum Biomarkers [ Time Frame: Days 1st, 15th and 30th after randomization ]
    Change on high sensitivity C-reactive protein (hsCRP) and D-Dimer

  8. Duration of Individual Symptoms [ Time Frame: 30 days ]
    Days of fever, cough, myalgia, dyspnea and headache



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517422


Locations
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Mexico
Hospital General Dr. Manuel Gea Gonzalez
Mexico city, Mexico, 14080
Sponsors and Collaborators
AB Biotics, SA
Innovacion y Desarrollo de Estrategias en Salud
Hospital General Dr. Manuel Gea González
Hospital Angeles del Pedregal
Publications of Results:

Other Publications:
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Responsible Party: AB Biotics, SA
ClinicalTrials.gov Identifier: NCT04517422    
Other Study ID Numbers: ABB-COVID19
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: From the moment of manuscript publication, without time limit.
Access Criteria: Formal request with a defined analysis plan. Please contact espadaler@ab-biotics.com or medical@ab-biotics.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Biotics, SA:
probiotics
sars-cov-2
covid-19
adults
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases