Efficacy of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis: A phase II clinical trial.
Lactobacillus
cystitis
probiotics
suppository
urinary tract infection
Journal
International journal of urology : official journal of the Japanese Urological Association
ISSN: 1442-2042
Titre abrégé: Int J Urol
Pays: Australia
ID NLM: 9440237
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
received:
16
03
2021
accepted:
04
06
2021
pubmed:
15
7
2021
medline:
16
10
2021
entrez:
14
7
2021
Statut:
ppublish
Résumé
To prospectively assess the efficacy and safety of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis. In this single-arm, open-label, phase II clinical trial, participants used vaginal suppositories containing the GAI 98322 strain of Lactobacillus crispatus for 1 year either every 2 days or three times per week. The primary end-point was the response rate, as assessed by the number of episodes of recurrent cystitis during the year of administration. The secondary end-points were the response rate, as assessed by episodes of recurrent cystitis during the 1 year after completion of the administration period; the total number of episodes of recurrent cystitis before, during and after administration; adverse events; and changes in urine bacteria and the vaginal microbiome. A total of 28 women were enrolled, and 21 completed the study. A total of 18 patients achieved an effective response (86%) during administration. The suppressive effects of Lactobacillus vaginal suppositories on episodes of cystitis continued up to 1 year after the last suppository was administered. There was a significant reduction in the mean number of episodes of cystitis, both during and after administration of Lactobacillus vaginal suppositories. No treatment-related adverse events were observed. Amplicon sequencing analysis of the vaginal microbiome showed that Lactobacillus species colonized the vagina during the periods when episodes of cystitis were absent. Vaginal suppositories containing the GAI 98322 strain of Lactobacillus crispatus effectively prevent episodes of recurrent cystitis, both during administration and for at least 1 year after administration.
Substances chimiques
Suppositories
0
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1026-1031Subventions
Organisme : Ministry of Education, Culture, Sports, Science and Technology of Japan
ID : JP17K10017
Organisme : Ministry of Education, Culture, Sports, Science and Technology of Japan
ID : JP17K11183
Organisme : Ministry of Education, Culture, Sports, Science and Technology of Japan
ID : JP20K18117
Organisme : Japanese Society of Chemotherapy Foundation
Informations de copyright
© 2021 The Japanese Urological Association.
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