Covid19PROBELDERLYNCT04922918
Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home
A study testing Ligilactobacillus salivarius MP101 in people with Covid19, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 74 to 98 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Ligilactobacillus salivarius MP101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 74 to 98 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living in the nursing home
- Informed consent obtained
Who cannot join
- Absence of informed consent
- Parenteral nutrition (exclusively)
- Allergy to cow's milk protein
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro Para Mayores Santa Isabel, S.L.
Moralzarzal, Madrid, 28411
Isabel Malder, MD, 34918421099, cpmsantaisabel@cpmsantaisabel.com
About this study
Official title: 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.
- Conditions
- Covid19
- Being tested
- Ligilactobacillus salivarius MP101
- Keywords
- covid-19, elderly, nursing home, probiotics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligilactobacillus salivarius MP101Biological
Administration of the strain through a fermented milk
| Study group | Role | What they receive |
|---|---|---|
| Probiotic arm | Experimental | Administration of Ligilactobacillus salivarius MP101 (>9 log10cfu, daily) for 4 months Receives: Biological: Ligilactobacillus salivarius MP101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
functional status score (daily activities)
Measured: 4 months
MNA score
Nutritional status
Measured: 4 months
nasal and fecal immune profile
37-plex
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Oct 2020
- Primary completion24 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan M. Rodríguez, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922918
- Sponsor's protocol ID
- CEIC 20/263-E_COVID
- Acronym
- PROBELDERLY
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Ligilactobacillus Salivarius MP101 in an Elderly Nursing Home During the COVID Pandemics
- ClinicalTrials.gov ID
- NCT04922918
- Acronym / sponsor ID
- PROBELDERLY / CEIC 20/263-E_COVID
- Conditions
- Covid19
- Keywords
- covid-19, elderly, nursing home, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 24 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic arm | Experimental | Biological: Ligilactobacillus salivarius MP101Administration of Ligilactobacillus salivarius MP101 (>9 log10cfu, daily) for 4 months |
Who may qualify
- Ages
- 74 to 98 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Living in the nursing home
- Informed consent obtained
Key exclusion criteria (3 listed)
- Absence of informed consent
- Parenteral nutrition (exclusively)
- Allergy to cow's milk protein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligilactobacillus salivarius MP101Administration of the strain through a fermented milk | Biological | Probiotic arm |
Primary outcome
Barthel index
Time frame: 4 months
functional status score (daily activities)
MNA score
Time frame: 4 months
Nutritional status
nasal and fecal immune profile
Time frame: 4 months
37-plex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligilactobacillus salivarius MP101 in people with Covid19, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Miguel Rodriguez, PhD (34913943749, jmrodrig@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel index (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.