NCT06474247

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

June 19, 2024

Last Update Submit

July 2, 2024

Conditions

Vaginal Candidiasis

Keywords

probioticpostbioticvaginal candidiasis

Outcome Measures

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

    4-weeks

Secondary Outcomes (2)

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

    4-weeks

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

    4-weeks

Study Arms (2)

Postbiotic

EXPERIMENTAL

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

Device: Postbiotic

Placebo

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

PostbioticDEVICE

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

Postbiotic
PlaceboDEVICE

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

Placebo

Eligibility Criteria

Age18 Years - 81 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with vaginal candidiasis
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Long term medication (6 months or more) for any illnesses
  • Pregnant
  • Menopaused
  • Uterus and/or cervix removed
  • Cervical intraepithelial neoplasia
  • Vaginal suppository treatments within 4-weeks prior to entering the study
  • Oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study
  • Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study
  • Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study
  • Have used spermicide agent within 4-weeks prior to entering the study
  • Have pelvic or any gynecologic surgery 6-months prior to entering the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sumita Hospital

Lucknow, Aliganj, 226024, India

RECRUITING

AIMST University

Bedong, Kedah, Malaysia

NOT YET RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Study Officials

  • Sumita Bhatia, MD

    Sumita Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumita Bhatia, MD

CONTACT

91923569755bhatiadrsumita@gmail.com

Min Tze Liong, PhD

CONTACT

604 653 2114mintze.liong@usm.my

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

June 2, 2024

Primary Completion

June 2, 2025

Study Completion

June 2, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)MY(1)