Therapeutic Lactose to Support Vaginal Microbiota

Peter Humaidan

Status: Completed

Conditions: Bacterial Vaginoses

Treatments: Dietary Supplement: Lactose; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03878511

2019_Lactose_microbiota

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Lactose

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactose

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo