NCT04517422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 19, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

August 16, 2020

Last Update Submit

May 2, 2021

Conditions

SARS-CoV Infection

Keywords

probioticssars-cov-2covid-19adults

Outcome Measures

Primary Outcomes (3)

  • Severity progression of COVID-19

    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

    Length of stay at Intensive Care Unit (ICU)

    30 days

  • Mortality ratio

    Mortality ratio for all causes related to COVID-19

    30 days

Secondary Outcomes (8)

  • Viral load

    30 days

  • Lung abnormalities

    30 days

  • Levels of immunoglobulins

    30 days

  • Gastrointestinal manifestations, where 0 means good health status and 5 worse status

    30 days

  • Fecal microbiome

    30 days

  • +3 more secondary outcomes

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ProbioticsDIETARY_SUPPLEMENT

Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483

Probiotics
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, 14080, Mexico

Location

Related Publications (8)

  • Zuo T, Liu Q, Zhang F, Lui GC, Tso EY, Yeoh YK, Chen Z, Boon SS, Chan FK, Chan PK, Ng SC. Depicting SARS-CoV-2 faecal viral activity in association with gut microbiota composition in patients with COVID-19. Gut. 2021 Feb;70(2):276-284. doi: 10.1136/gutjnl-2020-322294. Epub 2020 Jul 20.

    PMID: 32690600BACKGROUND

  • Bottari B, Castellone V, Neviani E. Probiotics and Covid-19. Int J Food Sci Nutr. 2021 May;72(3):293-299. doi: 10.1080/09637486.2020.1807475. Epub 2020 Aug 12.

    PMID: 32787470RESULT

  • Klann E, Rich S, Mai V. Gut Microbiota and Coronavirus Disease 2019 (COVID-19): A Superfluous Diagnostic Biomarker or Therapeutic Target? Clin Infect Dis. 2021 Jun 15;72(12):2247-2248. doi: 10.1093/cid/ciaa1191. No abstract available.

    PMID: 32780788RESULT

  • d'Ettorre G, Ceccarelli G, Marazzato M, Campagna G, Pinacchio C, Alessandri F, Ruberto F, Rossi G, Celani L, Scagnolari C, Mastropietro C, Trinchieri V, Recchia GE, Mauro V, Antonelli G, Pugliese F, Mastroianni CM. Challenges in the Management of SARS-CoV2 Infection: The Role of Oral Bacteriotherapy as Complementary Therapeutic Strategy to Avoid the Progression of COVID-19. Front Med (Lausanne). 2020 Jul 7;7:389. doi: 10.3389/fmed.2020.00389. eCollection 2020.

    PMID: 32733907RESULT

  • De Maio F, Posteraro B, Ponziani FR, Cattani P, Gasbarrini A, Sanguinetti M. Nasopharyngeal Microbiota Profiling of SARS-CoV-2 Infected Patients. Biol Proced Online. 2020 Jul 25;22:18. doi: 10.1186/s12575-020-00131-7. eCollection 2020.

    PMID: 32728349RESULT

  • Villena J, Kitazawa H. The Modulation of Mucosal Antiviral Immunity by Immunobiotics: Could They Offer Any Benefit in the SARS-CoV-2 Pandemic? Front Physiol. 2020 Jun 16;11:699. doi: 10.3389/fphys.2020.00699. eCollection 2020.

    PMID: 32670091RESULT

  • Marcialis MA, Bardanzellu F, Fanos V. Microbiota and Coronavirus Disease 2019. Which Came First, the Chicken or the Egg? Clin Infect Dis. 2021 Jun 15;72(12):2245-2246. doi: 10.1093/cid/ciaa965. No abstract available.

    PMID: 32645713RESULT

  • Aktas B, Aslim B. Gut-lung axis and dysbiosis in COVID-19. Turk J Biol. 2020 Jun 21;44(3):265-272. doi: 10.3906/biy-2005-102. eCollection 2020.

    PMID: 32595361RESULT

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

August 19, 2020

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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

Locations

ME(1)