Clinical trial · Interventional
Reducing Abundance of Human Papilloma Virus in Women by Taking Probiotic
The Effects of Probiotic Against Reducing Abundance of Human Papilloma Virus (HPV) in Women
NCT05316064CI-TRIAL-00077033withdrawnPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding problem
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| probiotic | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- probiotic 9 log CFU/day
- description
- Intervention consists of daily oral administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.
- interventionNames
- Biological: probiotic
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Changes in vaginal abundance of HPV of women upon administration of probiotic.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Sexually active women * Age above 26 years old * Determined as HPV positive against L1 variant * Willing to commit throughout the experiment Exclusion Criteria: * On long term medication (6 months and above) for any illnesses * Pregnant * Uterus and/or cervix removed * Prior HPV vaccination * Cervical intraepithelial neoplasia
References
Publications (3)
- DERIVEDXu 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 40884128
- DERIVEDXu P, Uma Mageswary M, Nisaa AA, Balasubramaniam SD, Samsudin SB, Rusdi NIBM, Jerip ARA, Oon CE, Bakar MHA, Tan JJ, Roslan FF, Kadir MN, Ismail EHBE, Sany SB, Tan CS, Liong MT. Impact of the Probiotic on the Modulation of Vaginal Bacterial and Fungal Microbiota in HPV-Positive Women. Mol Nutr Food Res. 2025 Sep;69(18):e70142. doi: 10.1002/mnfr.70142. Epub 2025 Jun 11. PMID 40495681
- DERIVEDXu 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 40360161