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Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

ABSTRACT: Urinary tract infections (UTIs) are common among women and frequently recur. Depletion of vaginal lactobacilli is associated with UTI risk, which suggests that repletion may be beneficial. We conducted a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic (Lactin-V; Osel) for prevention of recurrent UTI in premenopausal women.One hundred young women with a history of recurrent UTI received antimicrobials for acute UTI and then were randomized to receive either Lactin-V or placebo daily for 5 d, then once weekly for 10 weeks. Participants were followed up at 1 week and 10 weeks after intervention and for UTIs; urine samples for culture and vaginal swabs for real-time quantitative 16S ribosomal RNA gene polymerase chain reaction for L. crispatus were collected.Recurrent UTI occurred in 7/48 15% of women receiving Lactin-V compared with 13/48 27% of women receiving placebo (relative risk [RR], .5; 95% confidence interval, .2-1.2). High-level vaginal colonization with L. crispatus (?10(6) 16S RNA gene copies per swab) throughout follow-up was associated with a significant reduction in recurrent UTI only for Lactin-V (RR for Lactin-V, .07; RR for placebo, 1.1; P < .01).Lactin-V after treatment for cystitis is associated with a reduction in recurrent UTI. Larger efficacy trials of this novel preventive method for recurrent UTI are warranted. CLINICAL TRIALS REGISTRATION. NCT00305227.

SUBMITTER: Stapleton AE

PROVIDER: S-EPMC3079401 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

Stapleton Ann E AE Au-Yeung Melissa M Hooton Thomas M TM Fredricks David N DN Roberts Pacita L PL Czaja Christopher A CA Yarova-Yarovaya Yuliya Y Fiedler Tina T Cox Marsha M Stamm Walter E WE

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20110414 10

<h4>Background</h4>Urinary tract infections (UTIs) are common among women and frequently recur. Depletion of vaginal lactobacilli is associated with UTI risk, which suggests that repletion may be beneficial. We conducted a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic (Lactin-V; Osel) for prevention of recurrent UTI in premenopausal women.<h4>Methods</h4>One hundred young women with a history of recurrent UTI received antimicrobials for acu ...[more]

PMID: 21498386

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Project description:ImportanceRecurrent urinary tract infection (UTI) is a common debilitating condition in women, with limited prophylactic options. d-Mannose has shown promise in trials based in secondary care, but effectiveness in placebo-controlled studies and community settings has not been established.ObjectiveTo determine whether d-mannose taken for 6 months reduces the proportion of women with recurrent UTI experiencing a medically attended UTI.Design, setting, and participantsThis 2-group, double-blind randomized placebo-controlled trial took place across 99 primary care centers in the UK. Participants were recruited between March 28, 2019, and January 31, 2020, with 6 months of follow-up. Participants were female, 18 years or older, living in the community, and had evidence in their primary care record of consultations for at least 2 UTIs in the preceding 6 months or 3 UTIs in 12 months. Invitation to participate was made by their primary care center. A total of 7591 participants were approached, 830 responded, and 232 were ineligible or did not proceed to randomization. Statistical analysis was reported in December 2022.InterventionTwo grams daily of d-mannose powder or matched volume of placebo powder.Main outcomes and measuresThe primary outcome measure was the proportion of women experiencing at least 1 further episode of clinically suspected UTI for which they contacted ambulatory care within 6 months of study entry. Secondary outcomes included symptom duration, antibiotic use, time to next medically attended UTI, number of suspected UTIs, and UTI-related hospital admissions.ResultsOf 598 women eligible (mean [range] age, 58 [18-93] years), 303 were randomized to d-mannose (50.7%) and 295 to placebo (49.3%). Primary outcome data were available for 583 participants (97.5%). The proportion contacting ambulatory care with a clinically suspected UTI was 150 of 294 (51.0%) in the d-mannose group and 161 of 289 (55.7%) in the placebo group (risk difference, -5%; 95% CI, -13% to 3%; P = .26). Estimates were similar in per protocol analyses, imputation analyses, and preplanned subgroups. There were no statistically significant differences in any secondary outcome measures.Conclusions and relevanceIn this randomized clinical trial, daily d-mannose did not reduce the proportion of women with recurrent UTI in primary care who experienced a subsequent clinically suspected UTI. d-Mannose should not be recommended for prophylaxis in this patient group.Trial registrationisrctn.org Identifier: ISRCTN13283516.

Project description:BackgroundThe vaginal microbiota is associated with the health of the female reproductive system and the offspring. Lactobacillus crispatus belongs to one of the most important vaginal probiotics, while its role in the agglutination and immobilization of human sperm, fertility, and offspring health is unclear.MethodsAdherence assays, sperm motility assays, and Ca2+-detecting assays were used to analyze the adherence properties and sperm motility of L. crispatus Lcr-MH175, attenuated Salmonella typhimurium VNP20009, engineered S. typhimurium VNP20009 DNase I, and Escherichia coli O157:H7 in vitro. The rat reproductive model was further developed to study the role of L. crispatus on reproduction and offspring health, using high-throughput sequencing, real-time PCR, and molecular biology techniques.ResultsOur results indicated that L. crispatus, VNP20009, VNP20009 DNase I, and E. coli O157:H7 significantly inhibited the sperm motility in vitro via adversely affecting the sperm intracellular Ca2+ concentration and showed a high adhesion to sperms. The in vivo results indicated that L. crispatus and other tested bacteria greatly reduced the pregnancy rates, but L. crispatus had a positive effect on maternal health and offspring development. Moreover, the transplantation of L. crispatus could sustain a normal bacterial composition of the vaginal microbiota in healthy rats and markedly reduced the expression of uterine inflammatory factors (toll-like receptor-4/nuclear factor kappa-B, tumor necrosis factor-α, production of interleukin-1β, etc.) and apoptosis factors (Fas Ligand, Bcl-2-associated X protein/B cell lymphoma-2, etc.) compared with the other tested strains.ConclusionOur study demonstrated that the vaginal probiotic L. crispatus greatly affected the sperm activity and could also reduce pregnancies through its adhesion property, which might account for some unexplained infertility. Therefore, more caution should be paid when using L. crispatus as a vaginal viable preparation in women of child-bearing age, especially for women whose partners have abnormal sperms.

Project description:BackgroundPatients with lower neurogenic bladder dysfunction are at an increased risk of suffering from recurrent urinary tract infections. Recurrent symptomatic urinary tract infection is occasionally treated with antibiotics as a prophylactic prevention strategy. This risks increasing the frequency of antibiotic resistance. National healthcare policymakers have requested further research into alternative preventive measures for pathologies that require antibiotic treatment.MethodsThis study protocol describes a two-centre, randomised, double-blinded, placebo-controlled study to evaluate the prevention of recurrent urinary tract infections with the commercial immunotherapy agent Uro-Vaxom®, based on Escherichia coli pathogen-associated molecular patterns. Eligible participants are recruited by the direct healthcare team and randomised to receive Uro-Vaxom® in the form of an oral capsule, or a matching placebo. Participants will receive the study treatment daily for 3 months and followed up for an additional 3 months so that the number of symptomatic urinary tract infection episodes and individual signs and symptoms per episode can be recorded using participant study diaries. Primary outcome measures are: number of symptomatic urinary tract infections experienced over 3 months, number of symptomatic urinary tract infections experienced over 6 months, time from the start of treatment to the first urinary tract infection, and the presence of asymptomatic bacteriuria at 3 and 6 months. Secondary outcome measures are: individually recorded symptoms normally associated with recurrent urinary tract infection and consistency of reported symptoms during the symptomatic urinary tract infection experienced during the study, compliance with study protocol and study medication, and adverse events.DiscussionHealthcare policymakers recommend that alternative preventative strategies are identified for symptomatic urinary tract infections that require antibiotic treatment. If Uro-Vaxom® is shown to be effective, this feasibility study would warrant a larger, statistically powered, multicentre study to investigate whether this immunotherapy strategy is an effective preventative measure for recurrent symptomatic urinary tract infection for people with spinal cord injuries and neurological pathologies.Trial registrationISRTCN. Registered on 30 October 2015. ClinicalTrials.gov, ID: NCT0251901 . Registered on 30 October 2015. URL of trial registry record: Ethics Ref: 15-LO-2069. IRAS Number: 185760. Sponsor Number: RXQ/648. NIHR Funding Reference: PB-PG-1013-32017.

Dataset Information

Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

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Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

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