Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home

NCT ID: NCT04922918

Last Updated: 2021-06-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Probiotic arm

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

Group Type EXPERIMENTAL

Ligilactobacillus salivarius MP101

Intervention Type BIOLOGICAL

Administration of the strain through a fermented milk

Interventions

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Ligilactobacillus salivarius MP101

Administration of the strain through a fermented milk

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

74 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Juan M. Rodríguez

Head

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Para Mayores Santa Isabel, S.L.

Moralzarzal, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan Miguel Rodriguez, PhD

Role: CONTACT

34913943749

Leonides Fernández, PhD

Role: CONTACT

34913943745

Facility Contacts

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Isabel Malder, MD

Role: primary

34918421099

Other Identifiers

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CEIC 20/263-E_COVID

Identifier Type: -

Identifier Source: org_study_id

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