NCT03878511

Therapeutic Lactose to Support Vaginal Microbiota

Effect of Vaginal Lactose on the Vaginal Microbiota in Women With Bacterial Vaginosis: Double-blind, Placebo-controlled Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Peter Humaidan · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Vaginoses

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactose	Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg
DIETARY_SUPPLEMENT	Placebo	Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2019-03-18
• Last updated: 2019-03-19