NCT04922918

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 9, 2021

Last Update Submit

June 9, 2021

Conditions

Covid19

Keywords

covid-19elderlynursing homeprobiotics

Outcome Measures

Primary Outcomes (3)

  • Barthel index

    functional status score (daily activities)

    4 months

  • MNA score

    Nutritional status

    4 months

  • nasal and fecal immune profile

    37-plex

    4 months

Study Arms (1)

Probiotic arm

EXPERIMENTAL

Administration of Ligilactobacillus salivarius MP101 (\>9 log10cfu, daily) for 4 months

Biological: Ligilactobacillus salivarius MP101

Interventions

Ligilactobacillus salivarius MP101BIOLOGICAL

Administration of the strain through a fermented milk

Probiotic arm

Eligibility Criteria

Age74 Years - 98 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Living in the nursing home
  • Informed consent obtained

You may not qualify if:

  • Absence of informed consent
  • Parenteral nutrition (exclusively)
  • Allergy to cow's milk protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Para Mayores Santa Isabel, S.L.

Moralzarzal, Madrid, 28411, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Juan Miguel Rodriguez, PhD

CONTACT

34913943749jmrodrig@ucm.es

Leonides Fernández, PhD

CONTACT

34913943745leonides@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 11, 2021

Study Start

October 1, 2020

Primary Completion

June 24, 2021

Study Completion

July 1, 2021

Last Updated

June 11, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)