Therapeutic Lactose to Support Vaginal Microbiota

NCT03878511 | Completed

• 1 other identifier: 2019_Lactose_microbiota
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Vaginoses

Outcome Measures

Primary Outcomes (1)

• Bacterial load after intervention

  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

  7 days

Study Arms (2)

Lactose

EXPERIMENTAL

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

Dietary Supplement: Lactose

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Lactose DIETARY_SUPPLEMENT

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

Lactose

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH\>4.5 and Clue cells in a wet smear.

You may not qualify if:

• Not able to provide written informed consent.

Sponsors & Collaborators

• Peter Humaidan: lead

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Lactose

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 19, 2019

Record last verified: 2019-03