Health TrialsbyHealthPanel

Postbiotic as Adjunct Treatment for Vaginal Candidiasis

ConditionVaginal Candidiasis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-81
SponsorMin-Tze LIONG

About this trial

This project aims to study the efficacy of intravaginal administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women who are sexually active

Confirmed with candidiasis as confirmed via clinical observations which include creamy whitish vaginal discharge and vulva-vaginal itchiness

Willing to commit throughout the experiment

Disqualifiers

Long term medication (6 months or more) for any illnesses

Pregnant

Menopaused

Uterus and/or cervix removed

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postbiotic

    Device

    Postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks

  • Placebo

    Device

    Placebo at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: PostbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Microbiota profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via next generation sequencing

Differences in microbiota abundance of vaginal samples of women with vaginal candidiasis upon administration of postbiotic compared to placebo

Time frame
4-weeks

Secondary outcomes

1

Pathogenic yeasts profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via real time PCR

Differences in pathogenic yeasts abundance of vaginal samples of women with vaginal candidiasis upon administration of postbiotic compared to placebo

Time frame
4-weeks
2

Quality of life profiles of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via questionnaires

Differences in quality of life parameters of women with vaginal candidiasis upon administration of postbiotic compared to placebo

Time frame
4-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min-Tze LIONG

Lead sponsor

Universiti Sains Malaysia

Sponsor institution

AIMST University

Collaborator

Sumita Hospital

Collaborator

Source ClinicalTrials.gov
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