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Authors
Volkova, Oksana N.
Amel’chenko, Elena V.
Makeeva, Oksana V.
Tolmachev, Sergey A.
Lesovaya, Ekaterina A.
Zacharia, Lefteris C.
Dikovskiy, Alexander V.
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Article History
Received: 23 August 2024
Accepted: 17 February 2025
First Online: 20 February 2025
Declarations
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: The Natamycine + Lactulose-supp-12/21 study (Permission # #482 from 11.08.2022) was conducted from December 2022 to July 2023 in two countries: the Russian Federation (one study site) and the Republic of Belarus (five study sites). Prior to subjects` enrollment, the ethical approval was obtained from the Ethics Review Board of the Russian Ministry of Health (Abstract of Record No. 305 of March 22, 2022) and local ethics committees (Statement w/n of December 05, 2022 issued by the Institutional Review Board of Minsk Municipal Polyclinic No.4; Statement w/n of November 28, 2022 issued by the Institutional Review Board of Minsk Municipal Outpatients Clinic No.5; Statement w/n of December 05, 2022 issued by the Ethics Committee of Minsk Municipal Emergency Care Hospital; Statement w/n of December 02, 2022 issued by the Institutional Review Board of Minsk Frunzenskiy District Central Polyclinic No.2; Statement w/n of November 29, 2022 issued by the Institutional Review Board of Minsk Municipal Hospital No.1). The study was coordinated by the Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University and performed in compliance with the World Medical Association Declaration of Helsinki and the International Conference on Harmonization guidelines (Good Clinical Practice).Prior to enrollment, all participants received written and verbal explanations of the study's aims, objectives, and methods, as well as the potential benefits and risks associated with participation. The subject and investigator completed the informed consent form in duplicate, with dated handwritten signatures. The investigator kept the first copy of the signed informed consent forms in the Investigator File, while the second copy was given to the subject. The study was reported in accordance with the Consolidated Standards for Reporting Trials (CONSORT) guidelines (Additional file 1). The study reached a pre-specified level of significance for the primary efficacy endpoint (P < 0.01556) and was terminated at the interim analysis.
: Not applicable.
: OVM, SAT and EAL are employees of AVVA RUS JSC that produce the combination suppositories.
