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Therapeutic Lactose to Support Vaginal Microbiota

NCT03878511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peter Humaidan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2013-03-01
Completion
2013-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878511 on ClinicalTrials.gov