Ligilactobacillus Salivarius MP101 for Elderly in a Nursi... | NCT04922918

Studies
Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home

NCT04922918

Sponsor

Universidad Complutense de Madrid

Status

Unknown status

Last Update Posted

Jun 11, 2021Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Covid19

Interventions

Ligilactobacillus salivarius MP101

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Jun 24, 2021Estimated

Completion Date

Jul 1, 2021Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 9, 2021

First Posted Date

Jun 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2021

Last Update Posted Date

Jun 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan M. Rodríguez, Head, Universidad Complutense de MadridPrincipal Investigator

Lead Sponsor

Universidad Complutense de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic arm	Experimental	Administration of Ligilactobacillus salivarius MP101 (>9 log10cfu, daily) for 4 months	Biological: Ligilactobacillus salivarius MP101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ligilactobacillus salivarius MP101	Biological	Administration of the strain through a fermented milk	Probiotic arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

74 Years

Maximum Age

98 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juan Miguel Rodriguez, PhD	Contact	34913943749		jmrodrig@ucm.es
Leonides Fernández, PhD	Contact	34913943745		leonides@ucm.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Para Mayores Santa Isabel, S.L.	Recruiting	Moralzarzal	Madrid	28411	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided