Clinical trial · Interventional
Probiotic Implementation as Help in Solving Vaginal Infections
Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Over recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between Lactobacillus and other bacteria species in order to promote women's well-being. The aim of the study was to confirm that vaginal Lactobacilli long-lasting implementation in women with HPVinfections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ASC-US | — | UNRESOLVED | — |
| Vaginal Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus rhamnosus BMX 54 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group 1
- description
- Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
- interventionNames
- Other: Lactobacillus rhamnosus BMX 54
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
- interventionNames
- Other: Lactobacillus rhamnosus BMX 54
Primary outcomes (1)
- measure
- Evaluation of a possible role of probiotics in vaginal infections resolution
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age\>18 years * documented BV or yeast vaginitis associated with HPV-infection documented as PAP-smear abnormalities (ASCUS, L-SIL or H-SIL histologically demonstrated as CIN1) and/or positive for HPV-DNA Exclusion Criteria: * pregnancy or breastfeeding * previous abnormal PAP-smear * CIN2-3 * concomitant malignancies * immunological diseases * severe comorbidities * prolonged corticosteroid treatment.
References
Publications (2)
- BACKGROUNDRecine N, Palma E, Domenici L, Giorgini M, Imperiale L, Sassu C, Musella A, Marchetti C, Muzii L, Benedetti Panici P. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis. Arch Gynecol Obstet. 2016 Jan;293(1):101-107. doi: 10.1007/s00404-015-3810-2. Epub 2015 Jul 5. PMID 26142892
- DERIVEDPalma E, Recine N, Domenici L, Giorgini M, Pierangeli A, Panici PB. Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection. BMC Infect Dis. 2018 Jan 5;18(1):13. doi: 10.1186/s12879-017-2938-z. PMID 29304768