Vaginal Flora ImbalancePhase 4NCT05808816
"Lactobacillus Crispatus M247, LSIL and Microbiota"
A Phase 4 study testing Lactobacillus Crispatus M247 in people with Vaginal Flora Imbalance and ASC-US, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Flora Imbalance, ASC-US, LSIL
- What is being tested?
- Lactobacillus Crispatus M247
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2021to 30 Jun 2023
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pap smear ASCUS or L-SIL
- HPV test + (HPV-HR e/o HPV-LR)
Who cannot join
- Hormonal therapy (OC, ring, patch, implant)
- Pregnancy status
- Immunosuppressive therapies
- Ongoing HPV vaccination
Trial locations and contacts
1 site in 1 country.
Rosa Pasqualina RP De Vincenzo, Phd contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
Rosa Pasqualina RP De Vincenzo, PhD, +39 3393660390, rosapasqualina.devincenzo@policlinicogemelli.it
About this study
Official title: Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation
Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m
- Conditions
- Vaginal Flora Imbalance, ASC-US, LSIL, HPV Infection
- Being tested
- Lactobacillus Crispatus M247
- Medical subject headings
- Atypical Squamous Cells of the Cervix, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Crispatus M247Drug
Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patient with oral supplementation of Lactobacillus Crispatus M247 Receives: Drug: Lactobacillus Crispatus M247 |
| Arm B | No intervention | Patients without oral supplementation of Lactobacillus Crispatus M247 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test.
Measured: 5 months
Secondary outcomes (3)
Cytological regression and microbiological clearance of HPV infection
Measured: 5 months
Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient
Measured: 24 months
Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start16 Jun 2021
- Primary completion2 Feb 2023
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Flora ImbalanceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808816
- Sponsor's protocol ID
- ID 4010
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation
- ClinicalTrials.gov ID
- NCT05808816
- Acronym / sponsor ID
- ID 4010
- Conditions
- Vaginal Flora Imbalance, ASC-US, LSIL, HPV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Apr 2023 (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.
Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Lactobacillus Crispatus M247Patient with oral supplementation of Lactobacillus Crispatus M247 |
| Arm B | No intervention | –Patients without oral supplementation of Lactobacillus Crispatus M247 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pap smear ASCUS or L-SIL
- HPV test + (HPV-HR e/o HPV-LR)
Key exclusion criteria (4 listed)
- Hormonal therapy (OC, ring, patch, implant)
- Pregnancy status
- Immunosuppressive therapies
- Ongoing HPV vaccination
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 M247Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related | Drug | Arm A |
Primary outcome
To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test.
Time frame: 5 months
3 secondary outcomes
Cytological regression and microbiological clearance of HPV infection
Time frame: 5 months
Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient
Time frame: 24 months
Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
Related trials for Vaginal Flora Imbalance
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
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.
Rosa Pasqualina RP De Vincenzo, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus Crispatus M247 in people with Vaginal Flora Imbalance and ASC-US, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Pasqualina RP De Vincenzo, Phd (+0039 3393660390, rosapasqualina.devincenzo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test. (time frame: 5 months). 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 11 Apr 2023.