Efficacy of L. Plantarum and P. Acidilactici in Adults With SARS-CoV-2 and COVID-19
NCT ID: NCT04517422
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2020-08-19
2021-02-02
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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
Probiotics
Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483
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.
Placebo
Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0
Interventions
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Probiotics
Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483
Placebo
Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
60 Years
ALL
No
Sponsors
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Innovacion y Desarrollo de Estrategias en Salud
OTHER
Hospital General Dr. Manuel Gea González
OTHER_GOV
Hospital Angeles del Pedregal
OTHER
AB Biotics, SA
INDUSTRY
Responsible Party
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Locations
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Hospital General Dr. Manuel Gea Gonzalez
Mexico City, , Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ABB-COVID19
Identifier Type: -
Identifier Source: org_study_id
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