Back to resultsLigilactobacillus Salivarius MP101 for Elderly in a Nursing Home (PROBELDERLY)
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ligilactobacillus salivarius MP101
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring covid-19, elderly, nursing home, probiotics
Eligibility Criteria
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
Sites / Locations
- Centro Para Mayores Santa Isabel, S.L.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probiotic arm
Arm Description
Administration of Ligilactobacillus salivarius MP101 (>9 log10cfu, daily) for 4 months
Outcomes
Primary Outcome Measures
Barthel index
functional status score (daily activities)
MNA score
Nutritional status
nasal and fecal immune profile
37-plex
Secondary Outcome Measures
Full Information
NCT ID
NCT04922918
First Posted
June 9, 2021
Last Updated
June 9, 2021
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04922918
Brief Title
Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home
Acronym
PROBELDERLY
Official Title
Administration of Ligilactobacillus Salivarius MP101 in an Elderly Nursing Home During the COVID Pandemics
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 24, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid-19, elderly, nursing home, probiotics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic arm
Arm Type
Experimental
Arm Description
Administration of Ligilactobacillus salivarius MP101 (>9 log10cfu, daily) for 4 months
Intervention Type
Biological
Intervention Name(s)
Ligilactobacillus salivarius MP101
Intervention Description
Administration of the strain through a fermented milk
Primary Outcome Measure Information:
Title
Barthel index
Description
functional status score (daily activities)
Time Frame
4 months
Title
MNA score
Description
Nutritional status
Time Frame
4 months
Title
nasal and fecal immune profile
Description
37-plex
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
74 Years
Maximum Age & Unit of Time
98 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Miguel Rodriguez, PhD
Phone
34913943749
Email
jmrodrig@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Leonides Fernández, PhD
Phone
34913943745
Email
leonides@ucm.es
Facility Information:
Facility Name
Centro Para Mayores Santa Isabel, S.L.
City
Moralzarzal
State/Province
Madrid
ZIP/Postal Code
28411
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Malder, MD
Phone
34918421099
Email
cpmsantaisabel@cpmsantaisabel.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home
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