Clinical and microbiological efficacy of new probiotics in vaginal discharge disturbances

Clinical and microbiological efficacy of novel probiotics in vaginitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34840624

Enrollment

200

Registered

2017-02-13

Start date

2016-11-01

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginitis Infections and Infestations

Interventions

This study consists of two sub-studies in which participants are bacterial vaginosis (CRI-BV) or vaginal candidiasis (CRI-VC) patients. Sub-study 1 - CRI-BV: Participa

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: 1.1. Blood analysis (C-reactive protein, liver and renal function indices) taken by the gyneogologist at baseline and forth visit (90 days) 1.2 Microbiological culture and Amsel criteria testing by the gynecologist (vaginal swabs) at baseline visit 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)	—

Measure

Time frame

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: 1.1. Blood analysis (C-reactive protein, liver and renal function indices) taken by the gyneogologist at baseline and forth visit (90 days) 1.2 Microbiological culture and Amsel criteria testing by the gynecologist (vaginal swabs) at baseline visit 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)

—

Secondary

Measure	Time frame
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 2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains at baseline, after 20 days, 40 days, 60 days and 90 days 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	—

Measure

Time frame

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 2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains at baseline, after 20 days, 40 days, 60 days and 90 days 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

—

Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026