NCT05316064

Brief Summary

The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log colony forming unit (CFU)/day to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 27, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

March 17, 2022

Last Update Submit

May 8, 2024

Conditions

Human Papilloma Virus Infection

Keywords

probioticshuman papilloma virus

Outcome Measures

Primary Outcomes (1)

  • Changes in vaginal abundance of HPV of women upon administration of probiotic.

    Differences in vaginal HPV abundance in women upon administration of probiotic at 9 log CFU/day compared to placebo via real-time PCR quantification of the L1 capsid gene as a conserved region of the HPV genome using consensus primers PGMY09 and PGMY1.

    12-weeks

Secondary Outcomes (4)

  • Changes in vaginal microbiota of women upon administration of probiotic.

    12-weeks

  • Changes in gut microbiota of women upon administration of probiotic.

    12-weeks

  • Changes in vaginal health of women upon administration of probiotic via the use of questionnaire.

    12-weeks

  • Changes in immunity of women upon administration of probiotic 9 log CFU/day as assessed via biochemical tests.

    12-weeks

Study Arms (2)

probiotic 9 log CFU/day

EXPERIMENTAL

Intervention consists of daily oral administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.

Biological: probiotic

placebo

PLACEBO COMPARATOR

placebo contains primarily carrier without probiotic and it is identical in taste and appearance and appear as light-yellow powder. It is also taken by the participants for 12 weeks.

Other: placebo

Interventions

probioticBIOLOGICAL

oral administration of probiotic at 9 log CFU/day for 12 weeks to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab.

probiotic 9 log CFU/day
placeboOTHER

oral administration of primarily carrier without the probiotic for 12 weeks

placebo

Eligibility Criteria

Age26 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sexually active women
  • Age above 26 years old
  • Determined as HPV positive against L1 variant
  • Willing to commit throughout the experiment

You may not qualify if:

  • On long term medication (6 months and above) for any illnesses
  • Pregnant
  • Uterus and/or cervix removed
  • Prior HPV vaccination
  • Cervical intraepithelial neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Seberang Jaya

Pulau Pinang, Pulau Pinang, 13700, Malaysia

Location

Related Publications (2)

  • Xu P, Mageswary MU, Nisaa AA, Samsudin SB, Rusdi NIBM, Jerip ARA, Oon CE, Sany SB, Tan CS, Zhu ZH, Liong MT. Probiotic Lactiplantibacillus plantarum Probio87 Improves Gut Microbial Profiles in HPV-Positive Women: A Randomized, Placebo-Controlled and Double-Blind Study. Mol Nutr Food Res. 2025 Nov;69(22):e70247. doi: 10.1002/mnfr.70247. Epub 2025 Aug 30.

    PMID: 40884128DERIVED

  • Xu P, Mageswary U, Nisaa AA, Balasubramaniam SD, Samsudin SB, Rusdi NIBM, Jerip ARA, Oon CE, Bakar MHA, Rajendran D, Tan JJ, Roslan FF, Sreenivasan S, Balakrishnan V, Sany SB, Tan CS, Liong MT. Probiotic reduces vaginal HPV abundance, improves immunity and quality of life in HPV-positive women: a randomised, placebo-controlled and double-blind study. Benef Microbes. 2025 May 12;16(6):667-684. doi: 10.1163/18762891-bja00079.

    PMID: 40360161DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • MingTze Liong, Doctor

    School of Industrial Technology USM

    STUDY DIRECTOR

  • Binti Sany Salina, Doctor

    Institut Perubatan & Pergigian Termaju USM

    PRINCIPAL INVESTIGATOR
0

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 7, 2022

Study Start

December 27, 2021

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)