NCT05474144 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Adler Sørensen C, Fuglsang E, Jørgensen CS, Laursen RP, Larnkjær A, Mølgaard C, Ritz C, Michaelsen KF, Krogfelt KA, Frøkiær H
Probiotics and the immunological response to infant vaccinations; a double-blind randomized controlled trial. Clin Microbiol Infect. 2019 Apr;25(4):511.e1-511.e7. doi: 10.1016/j.cmi.2018.07.031. Epub 2018 Aug 9.
Baud D, Dimopoulou Agri V, Gibson GR, Reid G, Giannoni E
Using Probiotics to Flatten the Curve of Coronavirus Disease COVID-2019 Pandemic. Front Public Health. 2020 May 8;8:186. doi: 10.3389/fpubh.2020.00186. eCollection 2020.
Bottari B, Castellone V, Neviani E
Probiotics and Covid-19. Int J Food Sci Nutr. 2021 May;72(3):293-299. doi: 10.1080/09637486.2020.1807475. Epub 2020 Aug 12. Review.
Doron S, Snydman DR
Risk and safety of probiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2:S129-34. doi: 10.1093/cid/civ085. Review.
Li KJ, Chen ZL, Huang Y, Zhang R, Luan XQ, Lei TT, Chen L
Dysbiosis of lower respiratory tract microbiome are associated with inflammation and microbial function variety. Respir Res. 2019 Dec 3;20(1):272. doi: 10.1186/s12931-019-1246-0.
Nguyen QV, Chong LC, Hor YY, Lew LC, Rather IA, Choi SB
Role of Probiotics in the Management of COVID-19: A Computational Perspective. Nutrients. 2022 Jan 10;14(2). pii: 274. doi: 10.3390/nu14020274. Review.
Xu K, Cai H, Shen Y, Ni Q, Chen Y, Hu S, Li J, Wang H, Yu L, Huang H, Qiu Y, Wei G, Fang Q, Zhou J, Sheng J, Liang T, Li L
[Management of COVID-19: the Zhejiang experience]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 Feb 21;49(2):147-157. doi: 10.3785/j.issn.1008-9292.2020.02.02. Chinese.

A Two-arm, Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy of the Probiotic Dietary Supplement SmartProbio C in the Supportive Supplementation of Patients With a Complicated Course of COVID-19 Infection

Details for clinical trial NCT05474144

Clinical trial NCT05474144 - References