Therapeutic Lactose to Support Vaginal Microbiota

Bacterial Vaginoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878511
• Other study ID #: 2019_Lactose_microbiota
• Status: Completed
• Phase: N/A
• Start date: November 1, 2012
• Est. completion date: March 1, 2013

Study information

• Verified date: March 2019
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2013
• Est. primary completion date: March 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH>4.5 and Clue cells in a wet smear.

Exclusion Criteria:

• Not able to provide written informed consent.

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Dietary Supplement:
• Lactose
Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg
• Placebo
Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peter Humaidan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial load after intervention	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	7 days