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Therapeutic Lactose to Support Vaginal Microbiota

NCT ID: NCT03878511

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2013-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Vaginoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Lactose

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

Group Type EXPERIMENTAL

Lactose

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Lactose

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peter Humaidan

OTHER

Sponsor Role lead

Responsible Party

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Peter Humaidan

Professor, MD

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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2019_Lactose_microbiota

Identifier Type: -

Identifier Source: org_study_id

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