Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home (PROBELDERLY)

June 9, 2021 updated by: Juan M. Rodríguez, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Miguel Rodriguez, PhD
  • Phone Number: 34913943749
  • Email: jmrodrig@ucm.es

Study Contact Backup

  • Name: Leonides Fernández, PhD
  • Phone Number: 34913943745
  • Email: leonides@ucm.es

Study Locations

  • Spain
    • Madrid
      • Moralzarzal, Madrid, Spain, 28411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

74 years to 98 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotic arm
Administration of Ligilactobacillus salivarius MP101 (>9 log10cfu, daily) for 4 months
Biological: Ligilactobacillus salivarius MP101
Administration of the strain through a fermented milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index
Time Frame: 4 months
functional status score (daily activities)
4 months
MNA score
Time Frame: 4 months
Nutritional status
4 months
nasal and fecal immune profile
Time Frame: 4 months
37-plex
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

June 24, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (ACTUAL)

June 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 20/263-E_COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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