Human Papillomavirus InfectionNCT06802809
Efficacy of Probiotic Lactobacillus Crispatus M247 in Promoting High-risk Human Papillomavirus (HR-HPV) Infection Clearance and Modifying Vaginal Microbiota
A study testing Lactobacillus crispatus M247 (Crispact®) in people with Human Papillomavirus Infection, run by Liaquat University of Medical & Health Sciences at 3 sites in Italy.
Trial summary
This clinical trial evaluates the efficacy of the probiotic strain Lactobacillus crispatus M247 in promoting the clearance of genital high-risk human papillomavirus (HR-HPV) infection and restoring the balance of the vaginal microbiota. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Lactobacillus crispatus M247 (Crispact®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesItaly
- Study dates
- 5 Jan 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-69 years.
- First diagnosis of HR-HPV infection via DNA-HPV screening.
- Cytology results showing ASC-US or LSIL.
- Negative colposcopy or biopsy (absence of lesions).
- Ability to provide written informed consent.
Who cannot join
- Prior HPV vaccination.
- History of cervical treatments for pre-neoplastic pathology.
- Cytology showing HSIL (High-Grade Squamous Intraepithelial Lesion) requiring treatment.
- Current treatment with antibiotics, immunomodulatory, or immunosuppressive therapies.
- Diagnosed immune system or neoplastic diseases requiring chemotherapy.
- Pregnancy, lactation, or planning to become pregnant within 6 months.
- Known hypersensitivity to product components.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco"
Catania, 95121
Nuovo Ospedale di Lentini
Lentini, 96016
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo
Palermo, 90127
About this study
Official title: Evaluation of the Efficacy of Lactobacillus Crispatus M247 Administration in Promoting Clearance of Genital HR-HPV Infection and Modulating the Vaginal Microbiota: A Multicenter, Randomized, Placebo-Controlled, Single-Blind, Longitudinal, Prospective Clinical Trial
This clinical trial evaluates the efficacy of the probiotic strain Lactobacillus crispatus M247 in promoting the clearance of genital high-risk human papillomavirus (HR-HPV) infection and restoring the balance of the vaginal microbiota. The study adopts a multicenter, randomized, single-blind, longitudinal, prospective design involving HR-HPV-positive patients. Primary outcomes include HR-HPV clearance rates and microbiota composition changes.
Read the detailed description
This study investigates the potential benefits of Lactobacillus crispatus M247, a probiotic strain with proven ability to promote vaginal health, in the management of HR-HPV infections. Lactobacillus crispatus M247 has demonstrated superior probiotic properties, including the ability to produce lactic acid and hydrogen peroxide, which contribute to maintaining a stable vaginal microbiota and potentially inhibiting HR-HPV persistence.
Participants will be randomized to receive either Lactobacillus crispatus M247 or a placebo over a specified study period. The primary aim is to evaluate the probiotic's efficacy in enhancing HR-HPV clearance rates and restoring a balanced vaginal microbiota. Secondary objectives include assessing changes in cervical cytology and participant-reported outcomes on vaginal health. By focusing exclusively on the role of Lactobacillus crispatus M247, the study seeks to establish its clinical relevance in HR-HPV management and its potential as a therapeutic intervention.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Lactobacillus crispatus M247 (Crispact®), Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus crispatus M247 (Crispact®)Dietary supplement
Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247.
PlaceboOther
The placebo does not contain the active probiotic strain and consists of inactive excipients.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplement Lactobacillus crispatus M247 group | Experimental | Participants in this group will receive probiotic supplement Lactobacillus crispatus M247 (Crispact®) in stick form, administered orally at a dose of one stick per day for 4 months. Each stick contains 20 billion CFU of L. crispatus M247. Receives: Dietary Supplement: Lactobacillus crispatus M247 (Crispact®) |
| Control Group | Placebo comparator | Participants in the control group will receive a placebo identical in appearance and packaging to the experimental product, administered orally at a dose of one stick per day for 4 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR-HPV Clearance Rate
Percentage of participants in whom HR-HPV infection is no longer detectable, as assessed by an HPV-DNA test.
Measured: Baseline to 4 months post-intervention
Secondary outcomes (4)
Modifications in Vaginal Microbiota
Changes in the composition of the vaginal microbiota, including the abundance of Lactobacillus species (especially Lactobacillus crispatus) and microbiota diversity indices, as assessed by Next-Generation Sequencing of the 16S ribosomal RNA gene (NGS 16S) sequencing.
Measured: Baseline to 4 months post-intervention.
Microbiota Characteristics Favoring HR-HPV Infection or Clearance
Identification of vaginal microbiota profiles (e.g., CST-I (Community State Type-I) to CST-IV (Community State Type-IV) distribution) associated with HR-HPV persistence or clearance, as determined by NGS 16S sequencing
Measured: Baseline to 4 months post-intervention.
Cervical Cytology Normalization
Proportion of participants with normalization of cervical cytology results, transitioning from ASC-US (Atypical Squamous Cells of Undetermined Significance) or LSIL (Low-Grade Squamous Intraepithelial Lesion) to normal cytology, as determined by Papanicolaou (Pap) test analysis.
Measured: Baseline to 4 months post-intervention.
Number of patients reporting side effects to probiotic Crispact® intake
Number and type of adverse events reported, including gastrointestinal symptoms, allergic reactions, or other health concerns, as recorded in participant safety logs.
Measured: From baseline to 4 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start5 Jan 2022
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, multicenter, randomized, placebo-cntrolled, longitudinal, prospective, single-blind, parallel-group study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802809
- Sponsor's protocol ID
- Protocol n° 774/18.10.2021/AK
- Status last verified
- May 2025
- First submitted
- 25 Jan 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Lactobacillus Crispatus M247 Administration in Promoting Clearance of Genital HR-HPV Infection and Modulating the Vaginal Microbiota: A Multicenter, Randomized, Placebo-Controlled, Single-Blind, Longitudinal, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06802809
- Acronym / sponsor ID
- Protocol n° 774/18.10.2021/AK
- Conditions
- Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the efficacy of the probiotic strain Lactobacillus crispatus M247 in promoting the clearance of genital high-risk human papillomavirus (HR-HPV) infection and restoring the balance of the vaginal microbiota. The study adopts a multicenter, randomized, single-blind, longitudinal, prospective design involving HR-HPV-positive patients. Primary outcomes include HR-HPV clearance rates and microbiota composition changes.
Detailed description
This study investigates the potential benefits of Lactobacillus crispatus M247, a probiotic strain with proven ability to promote vaginal health, in the management of HR-HPV infections. Lactobacillus crispatus M247 has demonstrated superior probiotic properties, including the ability to produce lactic acid and hydrogen peroxide, which contribute to maintaining a stable vaginal microbiota and potentially inhibiting HR-HPV persistence.
Participants will be randomized to receive either Lactobacillus crispatus M247 or a placebo over a specified study period. The primary aim is to evaluate the probiotic's efficacy in enhancing HR-HPV clearance rates and restoring a balanced vaginal microbiota. Secondary objectives include assessing changes in cervical cytology and participant-reported outcomes on vaginal health. By focusing exclusively on the role of Lactobacillus crispatus M247, the study seeks to establish its clinical relevance in HR-HPV management and its potential as a therapeutic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental, multicenter, randomized, placebo-cntrolled, longitudinal, prospective, single-blind, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplement Lactobacillus crispatus M247 group | Experimental | Dietary Supplement: Lactobacillus crispatus M247 (Crispact®)Participants in this group will receive probiotic supplement Lactobacillus crispatus M247 (Crispact®) in stick form, administered orally at a dose of one stick per day for 4 months. Each stick contains 20 billion CFU of L. crispatus M247. |
| Control Group | Placebo comparator | Other: PlaceboParticipants in the control group will receive a placebo identical in appearance and packaging to the experimental product, administered orally at a dose of one stick per day for 4 months. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18-69 years.
- First diagnosis of HR-HPV infection via DNA-HPV screening.
- Cytology results showing ASC-US or LSIL.
- Negative colposcopy or biopsy (absence of lesions).
- Ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Prior HPV vaccination.
- History of cervical treatments for pre-neoplastic pathology.
- Cytology showing HSIL (High-Grade Squamous Intraepithelial Lesion) requiring treatment.
- Current treatment with antibiotics, immunomodulatory, or immunosuppressive therapies.
- Diagnosed immune system or neoplastic diseases requiring chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus crispatus M247 (Crispact®)Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247. | Dietary supplement | Probiotic supplement Lactobacillus crispatus M247 group |
| PlaceboThe placebo does not contain the active probiotic strain and consists of inactive excipients. | Other | Control Group |
Primary outcome
HR-HPV Clearance Rate
Time frame: Baseline to 4 months post-intervention
Percentage of participants in whom HR-HPV infection is no longer detectable, as assessed by an HPV-DNA test.
4 secondary outcomes
Modifications in Vaginal Microbiota
Time frame: Baseline to 4 months post-intervention.
Microbiota Characteristics Favoring HR-HPV Infection or Clearance
Time frame: Baseline to 4 months post-intervention.
Cervical Cytology Normalization
Time frame: Baseline to 4 months post-intervention.
Number of patients reporting side effects to probiotic Crispact® intake
Time frame: From baseline to 4 months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus crispatus M247 (Crispact®) in people with Human Papillomavirus Infection, run by Liaquat University of Medical & Health Sciences at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR-HPV Clearance Rate (time frame: Baseline to 4 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.