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NCT04922918 Clinical Trial

Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home

Covid19 Clinical Trial

— PROBELDERLY  

Official title:
Administration of Ligilactobacillus Salivarius MP101 in an Elderly Nursing Home During the COVID Pandemics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04922918
Other study ID # CEIC 20/263-E_COVID
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date July 1, 2021

Study information
Verified date June 2021
Source Universidad Complutense de Madrid
Contact Juan Miguel Rodriguez, PhD
Phone 34913943749
Email jmrodrig@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this work was to investigate the effect of Ligilactobacillus salivarius MP101 on the functional (Barthel index), cognitive (GDS/FAST) and nutritional (MNA) status, and on the nasal and fecal inflammatory profiles of elderly living in a nursing home highly affected by COVID-19.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date July 1, 2021
Est. primary completion date June 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 74 Years to 98 Years
Eligibility Inclusion Criteria: - Living in the nursing home - Informed consent obtained Exclusion Criteria: - Absence of informed consent - Parenteral nutrition (exclusively) - Allergy to cow's milk protein

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Ligilactobacillus salivarius MP101
Administration of the strain through a fermented milk

Locations
Country Name City State
Spain Centro Para Mayores Santa Isabel, S.L. Moralzarzal Madrid

Sponsors (1)
Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Barthel index functional status score (daily activities) 4 months
Primary MNA score Nutritional status 4 months
Primary nasal and fecal immune profile 37-plex 4 months
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