Therapeutic Lactose to Support Vaginal Microbiota
- Conditions
- Bacterial Vaginoses
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Lactose
- Registration Number
- NCT03878511
- Lead Sponsor
- Peter Humaidan
- Brief Summary
The aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV).
Design: Double-blind, placebo-controlled randomised trial.
Setting: Women with BV who responded to advertisements in local newspapers and on posters at the Institutions for Education in Health Science in Eastern Jutland, Denmark. These individuals were supplemented with patients enrolled at a gynaecological clinic.
Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets.
Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH>4.5 and Clue cells in a wet smear.
- Not able to provide written informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg Lactose Lactose Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg
- Primary Outcome Measures
Name Time Method Bacterial load after intervention 7 days quantitative measurements with qPCR for G. vaginalis, Prevotella spp., A. vaginae, Megasphaera type 1, L. gasseri, L. crispatus, L. jensenii and L. iners after intervention
- Secondary Outcome Measures
Name Time Method