NCT05316064 is a Phase 2, PHASE3 clinical trial of probiotic in Human Papilloma Virus Infection, sponsored by Universiti Sains Malaysia.

Who is sponsoring NCT05316064?

NCT05316064 is sponsored by Universiti Sains Malaysia.

What drugs are being tested in NCT05316064?

Interventions in NCT05316064: probiotic, placebo.

What condition does NCT05316064 study?

NCT05316064 studies Human Papilloma Virus Infection.

Is NCT05316064 still recruiting?

NCT05316064 is currently withdrawn. Last updated 10 May 2024.

Last reviewed 2024-05-10 · How we verify

NCT05316064

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic

Withdrawn Phase 2, PHASE3 Last updated 10 May 2024

What this trial tests

Phase 2, PHASE3 trial testing probiotic in Human Papilloma Virus Infection. Withdrawn.

Timeline

27 December 2021

Primary endpoint
28 November 2023

28 November 2023

Quick facts

Lead sponsor	Universiti Sains Malaysia
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	27 December 2021
Primary completion	28 November 2023
Estimated completion	28 November 2023
Sites	1 location across Malaysia

Drugs / interventions tested

probiotic
placebo

Conditions studied

Human Papilloma Virus Infection — all drugs for Human Papilloma Virus Infection →

Sponsor

Universiti Sains Malaysia — full company profile →

Who can join

26 and older, female only, with Human Papilloma Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Probiotic reduces vaginal HPV abundance, improves immunity and quality of life in HPV-positive women: a randomised, placebo-controlled and double-blind study.
Xu P, Mageswary U, Nisaa AA, Balasubramaniam SD, et al · · 2025 · cited 2× · PMID 40360161 · DOI 10.1163/18762891-bja00079
Probiotic Lactiplantibacillus plantarum Probio87 Improves Gut Microbial Profiles in HPV-Positive Women: A Randomized, Placebo-Controlled and Double-Blind Study.
Xu P, Mageswary MU, Nisaa AA, Samsudin SB, et al · · 2025 · PMID 40884128 · DOI 10.1002/mnfr.70247

Verify or expand the search:

Other trials of probiotic

Trials testing the same drug.

NCT05544396 — Study on the Probiotics Regulating miRNA in H. Pylori-induced Wnt/β-catenin Gastric Carcinogenesis. · NA · active not recruiting
NCT05917392 — Effects of Kimchi Supplementation on Gut Microbiota, DNA Methylation and Serum Proteomes · NA · unknown
NCT05894746 — Gfree - For Improved Blood Sugar and Reduced Inflammation. · NA · recruiting
NCT05710575 — Role of Probiotic Use in Outcomes of Premature Birth · NA · completed
NCT04939974 — Probiotic in Autism · NA · unknown

Other recruiting trials for Human Papilloma Virus Infection

Currently open trials in the same condition.

NCT06467942 — Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection · NA · recruiting

Other Universiti Sains Malaysia trials

Trials by the same sponsor.

NCT07397104 — Validity of a Self-reported Questionnaire for Periodontal Status in a Saudi Population · not yet recruiting
NCT07279324 — Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease · NA · not yet recruiting
NCT07338045 — The Effects of Eight-Week Baduanjin Exercise on Chronic Low Back Pain and Disability Among Office Workers. · NA · not yet recruiting
NCT07410351 — Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi · not yet recruiting
NCT07448909 — Cognitive-Frailty Gait Biomechanics for Early Dementia Detection · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05316064 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universiti Sains Malaysia
Last refreshed: 10 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05316064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing