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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03878511

Enrollment

Registered

2019-03-18

Start date

2012-11-01

Completion date

2013-03-01

Last updated

2019-03-19

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

Conditions

Bacterial Vaginoses

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.

Interventions

DIETARY_SUPPLEMENTLactose

Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg

DIETARY_SUPPLEMENTPlacebo

Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Active and inactive tablets were identical. The tablets were packed and labelled by the manufacturer. The key to identity was retained and was disclosed after recruiting all patients. After informed consent, eligible patients drew a closed opaque envelope from a set of envelopes numbered 1-40 and placed in random order. The envelope contained both number labels for medical data-related documents and sample vials and a closed opaque container holding tablets labelled with the sample number.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026