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Therapeutic Lactose to Support Vaginal Microbiota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03878511
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : March 19, 2019
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginoses Dietary Supplement: Lactose Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Effect of Vaginal Lactose on the Vaginal Microbiota in Women With Bacterial Vaginosis: Double-blind, Placebo-controlled Randomised Trial
Actual Study Start Date : November 1, 2012
Actual Primary Completion Date : March 1, 2013
Actual Study Completion Date : March 1, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: Lactose
Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg
Dietary Supplement: Lactose
Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg

Placebo Comparator: Placebo
Dextran 40 EP 671 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

Primary Outcome Measures :
  1. Bacterial load after intervention [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

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Responsible Party: Peter Humaidan, Professor, MD, Regionshospitalet Viborg, Skive Identifier: NCT03878511     History of Changes
Other Study ID Numbers: 2019_Lactose_microbiota
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Trace Elements
Growth Substances
Physiological Effects of Drugs