drugset / Trial / NCT04446572
Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin
Phase 2
Completed
58 enrolled
Universidad Complutense de Madrid
Bisearch Life · collabCentro de Diagnóstico Médico. Ayuntamiento de Madrid. · collab
Non-randomizedParallel-groupOpen-labelBasic science
Summary
In this study, we aimed to assess the cervicovaginal environment (pH, Nugent score, soluble immune factors and bacterial profile) in women with reproductive failure because of either repetitive abortion or infertility of unknown origin and compare it to that of healthy fertile women. The second objective was to evaluate the ability of Lactobacillus salivarius CECT5713 to modulate such parameters and to increase pregnancy rates in women with reproductive failure. The administration of L. salivarius CECT5713 (\~9 log10 colony-forming units (CFU)/day) for 6 months or until a diagnosis of pregnancy to women with reproductive failure resulted in an overall successful (term) pregnancy rate of 56%.
Timeline
- Start
- 2018-10-16
- Primary completion
- 2019-11-29
- Completion
- 2019-11-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactobacillus salivarius CECT5713 | Other / unclassified | 50 mg | Oral |