Clinical and microbiological efficacy of new probiotics in vaginal discharge disturbances

Not Applicable

Completed

• Conditions: Vaginitis; Infections and Infestations

• Registration Number: ISRCTN34840624
• Lead Sponsor: Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36856121/ (added 02/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-13
• Study Completion: 2019-12-31
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

Sub-study 1 - CRI-BV
1. Female
2. Aged between 18 and 50 years
3. Recurrent bacterial vagionosis episodes (diagnosed with complaints and through Amsel criteria, confirmation with microscopy in 2 days)

Sub-study 2 - CRI-VC
1. Female
2. Aged between 18 and 50 years
3. Recurrent vaginal candidiasis episodes (diagnosed with complaints and clinical signs confirmation with culture testing in 2 days)

Exclusion Criteria

Sub-study 1 - CRI-BV
1. Pregnancy
2. Breastfeeding
3. Aged under 18 years or over 50 years
4. Sexually transmitted infections
5. Diagnosis of vaginal candidiasis

Sub-study 2 - CRI-VC
1. Pregnancy
2. Breat feeding
3. Aged under 18 years or over 50 years
4. Sexually transmitted infections
5. Diagnosis of bacterial vaginosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1.Safety and tolerability of consumption of probiotic capsules (3 different L. crispatus strains in vaginal capsules and 2 different L. crispatus strains in oral capsules) is assessed through:<br> 1.1. Blood analysis (C-reactive protein, liver and renal function indices) taken by the gyneogologist at baseline and forth visit (90 days)<br> 1.2 Microbiological culture and Amsel criteria testing by the gynecologist (vaginal swabs) at baseline visit<br> 1.3 A questionnaire designed for the purpose of this study containing questions on wellbeing, habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, stool frequency) and changes in discharge at baseline, first, second and third visit (after 20, 40 and 60 days)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Total Lactobacillus counts are measured using cultures from faecal samples and vaginal swabs at baseline, after 20 days, 40 days, 60 days and 90 days<br> 2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains at baseline, after 20 days, 40 days, 60 days and 90 days<br> 3. Total bacterial account (Lactobacillus, Gardnerella vaginalis, Mobiluncus) is measured by assessing Nugent score level at at baseline, after 20 days, 40 days, 60 days and 90 days<br>