Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly

NCT04756466 | Completed DMC

• 1 other identifier: P055
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this trial is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in elderly population living in a nursing home. In addition, it will be evaluated if the probiotic strain have some effect on the immune response generated by the Covid-19 vaccine inthis population.

Conditions

SARS CoV-2 Infection; Elderly

Keywords

Probiotics; COVID19

Outcome Measures

Primary Outcomes (1)

• Incidence of SARS CoV-2 infection.

  Incidence of SARS CoV-2 infection confirmed by PCR or antigen test

  3 months

Secondary Outcomes (11)

• Incidence of hospital admissions caused by SARS-CoV-2 infection .

  3 months

• Incidence of ICU admissions caused by SARS-CoV-2 infection

  3 months

• Incidence of pneumonia caused by SARS-CoV-2 infection .

  3 months

• Incidence of need for oxygen support due to SARS-CoV-2 infection..

  3 months

• Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.

  3 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months

Dietary Supplement: Placebo

Probiotic group

EXPERIMENTAL

Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months

Dietary Supplement: Lactobacillus

Interventions

Placebo DIETARY_SUPPLEMENT

Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits

Control group

Lactobacillus DIETARY_SUPPLEMENT

Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits

Probiotic group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person over 60 years of age.
• Intern in residence for the elderly.
• Sign informed consent.

You may not qualify if:

• Person who at some previous time has tested positive for detection of COVID-19 by PCR or serology.
• Person who at the time of starting the intervention presents symptoms compatible with COVID-19.
• Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.

Sponsors & Collaborators

• Biosearch S.A.: lead

Study Sites (3)

Residencia San Marcos

Santiago de Compostela, A Coruña, 15820, Spain

Location

Residencia Santa Olalla

Santiago de Compostela, A Coruña, 15881, Spain

Location

Residencia San Simon de Ons

Santiago de Compostela, A Coruña, 15883, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mónica Olivares, PhD

  Biosearch S.A.

  STUDY DIRECTOR

• Anxo Fernandez-Ferreiro, PhD

  Complejo Hospitalario Universitario de Santiago Compostela

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 16, 2021
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)