NCT04937556: PROVID

Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).

Completed NA Last updated 31 May 2022

What this trial tests

NA trial testing Probiotic: Lactobacillus salivarius + Vit D + Zinc in Covid19 in 41 participants. Completed in 30 April 2022.

Timeline

25 October 2021

Primary endpoint
25 March 2022

30 April 2022

Quick facts

Lead sponsor	ProbiSearch SL
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	41
Start date	25 October 2021
Primary completion	25 March 2022
Estimated completion	30 April 2022
Sites	1 location across Spain

Drugs / interventions tested

• Probiotic: Lactobacillus salivarius + Vit D + Zinc
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

ProbiSearch SL — full company profile →

Who can join

Adults 18 to 65, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.

The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evidences and perspectives of the use of probiotics, prebiotics, synbiotics, and postbiotics as adjuvants for prevention and treatment of COVID-19: A bibliometric analysis and systematic review.
   Xavier-Santos D, Padilha M, Fabiano GA, Vinderola G, et al · · 2022 · cited 76× · PMID 35002079 · DOI 10.1016/j.tifs.2021.12.033
2. Zinc and selenium supplementation in COVID-19 prevention and treatment: a systematic review of the experimental studies.
   Balboni E, Zagnoli F, Filippini T, Fairweather-Tait SJ, et al · · 2022 · cited 44× · PMID 35217499 · DOI 10.1016/j.jtemb.2022.126956
3. Probiotics and prebiotics: potential prevention and therapeutic target for nutritional management of COVID-19?
   Batista KS, de Albuquerque JG, Vasconcelos MHA, Bezerra MLR, et al · · 2023 · cited 33× · PMID 34668465 · DOI 10.1017/s0954422421000317
4. Gut Microbiota and COVID-19: Potential Implications for Disease Severity.
   Rocchi G, Giovanetti M, Benedetti F, Borsetti A, et al · · 2022 · cited 19× · PMID 36145482 · DOI 10.3390/pathogens11091050
5. The impact of infection with COVID-19 on the respiratory microbiome: A narrative review.
   Zhu T, Jin J, Chen M, Chen Y. · · 2022 · cited 14× · PMID 35763685 · DOI 10.1080/21505594.2022.2090071
6. COVID-19 and Gut Injury.
   Shen S, Gong M, Wang G, Dua K, et al · · 2022 · cited 12× · PMID 36297092 · DOI 10.3390/nu14204409
7. Probiotics: A gut response to the COVID-19 pandemic but what does the evidence show?
   Brahma S, Naik A, Lordan R. · · 2022 · cited 11× · PMID 36184201 · DOI 10.1016/j.clnesp.2022.08.023
8. Association of SARS-CoV-2 and Polypharmacy with Gut-Lung Axis: From Pathogenesis to Treatment.
   Malik JA, Ahmed S, Yaseen Z, Alanazi M, et al · · 2022 · cited 11× · PMID 36164411 · DOI 10.1021/acsomega.2c02524