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A randomised controlled trial of lactobacillus in general practice to prevent post-antibiotic vulvovaginitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24141277
Enrollment
496
Registered
2002-10-08
Start date
2004-07-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-antibiotic vulvovaginitis Infections and Infestations Post-antibiotic vulvovaginitis

Interventions

Factorial design to test oral and vaginal lactobacillus species.

Sponsors

University of Melbourne (Australia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged between 18 and 50 years of age 2. Who are experiencing a non-genital infection 3. Rrequiring a short-course of oral antibiotics or have commenced this within the 48 hours preceding enrolment 4. English-speaking: able to speak, read and write in English sufficiently to provide informed consent and complete surveys

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Experiencing any vaginal symptoms at recruitment 3. Unwilling or unable to provide two self-collected low vaginal swabs (at recruitment and on completion of trial) 4. Using or have used vaginal antifungal treatments in the past two weeks 5. Have taken antibiotics in the past month 6. Unwilling to stop taking other lactobacillus products during the trial 7. Immunocompromised, as there are rare reports in the literature of lactobacilli causing endocarditis and bacteraemia

Design outcomes

Primary

MeasureTime frame
The primary outcome is symptomatic vulvovaginal candidiasis, defined as: 1. Participants' report of symptoms (that is answer 'yes' to a question about symptoms of 'thrush' in survey 2: vaginal itch, irritation with or without a discharge) 2. Swab B culture positive for Candida species

Secondary

MeasureTime frame
No secondary outcome measures

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026