Human Papillomavirus InfectionNCT06245486
Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-risk Human Papilloma (HPV-HR) Viruses
A study testing Crispact® in people with Human Papillomavirus Infection, run by Liaquat University of Medical & Health Sciences.
Trial summary
There is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (HPV) infection and reducing the risk of developement of cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Crispact®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2024to 31 Mar 2025
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women able to understand and agree to participation in the study and be able to provide written informed consent to the trial.
- Women aged 25-29 years who perform screening pap smears with the result: Low- grade squamous intraepithelial lesion (LSIL) or Atypical Squamous Cells of Undetermined Significanc (ASCUS) (for which, as per the recommendation of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)/Italian Group of Cervical Cancer. Screening (GISCI), no treatment is indicated but only follow-up with Human papillomavirus (HPV) test at 12 months.
- Women aged 18-64 who independently perform a positive High risk sub-types of HPV (HR-HPV) test outside of screening even in the presence of a negative cytology (for whom, as per the recommendation of the SICPCV, no treatment is indicated but only follow-up with HPV test at 12 months).
- Women aged 30-64 years HPV HR positive with negative cytology or with positive cytology for ASCUS or LSIL but negative colposcopy (absence of colposcopic lesion or positive colposcopy but subsequent negative biopsy) who do not require treatment (therefore as per the recommendation of the SICPCV go to follow-up with HPV testing at 12 months).
Who cannot join
- Women who have been vaccinated for HPV.
- Patients who have undergone cervical treatments for preneoplastic pathology.
- Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) cytological result who on histological examination after biopsy need treatment according to the SICPCV 2019 recommendations.
- Hypersensitivity to one or more components of the product.
- Patients being treated with antibiotic, immunomodulatory and immunosuppressive therapies.
- Patients with immune system or neoplastic pathologies being treated with chemotherapy
- Patients who are pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
Trial locations and contacts
No sites are listed yet.
Dr. Amjad Khan, DPhil contact
About this study
Official title: Study on the Efficacy of Crispact® (Probiotic Containing Lactobacillus Crispatus M247) in the Sterilization of HPV-HR and in the Reconstitution of the Normal Vaginal Microbiota
There is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (HPV) infection and reducing the risk of developement of cervical cancer.
Read the detailed description
This is a multicenter, randomized, longitudinal, prospective, parallel-group, single-blind study aimed to investigate the efficacy of probiotic Crispact® (which contains: 20 Bld CFU/Stick of Lactobacillus crispatus M247) in clearance of human papillomavirus (HPV) infection in healthy female who tested positive for human papillomavirus (HPV) infection.
- Conditions
- Human Papillomavirus Infection
- Being tested
- 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.
Crispact®Dietary supplement
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Young Group (Women aged 18-29 years) | Experimental | Participants in this group will take probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247) as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. Receives: Dietary Supplement: Crispact® |
| Control Young Group (Women aged 18-29 years) | Active comparator | Participants in this group will take Placebo as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. Receives: Dietary Supplement: Placebo |
| Probiotic Lady Group (Women aged 30-64 years) | Experimental | Participants in this group will take probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247) as 1 sachet oral per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. Receives: Dietary Supplement: Crispact® |
| Control Lady Group (Women aged 18-29 years) | Active comparator | Participants in this group will take Placebo as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human papillomavirus (HPV) clearance
Testing negative for HPV
Measured: After 4-months
Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)
Changes in vaginal microbiota
Measured: After 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
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
- Probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
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
- NCT06245486
- Sponsor's protocol ID
- 774/18.10.2021
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Crispact® (Probiotic Containing Lactobacillus Crispatus M247) in the Sterilization of HPV-HR and in the Reconstitution of the Normal Vaginal Microbiota
- ClinicalTrials.gov ID
- NCT06245486
- Acronym / sponsor ID
- 774/18.10.2021
- Conditions
- Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Feb 2024 (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.
There is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (HPV) infection and reducing the risk of developement of cervical cancer.
Detailed description
This is a multicenter, randomized, longitudinal, prospective, parallel-group, single-blind study aimed to investigate the efficacy of probiotic Crispact® (which contains: 20 Bld CFU/Stick of Lactobacillus crispatus M247) in clearance of human papillomavirus (HPV) infection in healthy female who tested positive for human papillomavirus (HPV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247)
| Arm | Type | Receives |
|---|---|---|
| Probiotic Young Group (Women aged 18-29 years) | Experimental | Dietary Supplement: Crispact®Participants in this group will take probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247) as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. |
| Control Young Group (Women aged 18-29 years) | Active comparator | Dietary Supplement: PlaceboParticipants in this group will take Placebo as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. |
| Probiotic Lady Group (Women aged 30-64 years) | Experimental | Dietary Supplement: Crispact®Participants in this group will take probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247) as 1 sachet oral per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. |
| Control Lady Group (Women aged 18-29 years) | Active comparator | Dietary Supplement: PlaceboParticipants in this group will take Placebo as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women able to understand and agree to participation in the study and be able to provide written informed consent to the trial.
- Women aged 25-29 years who perform screening pap smears with the result: Low- grade squamous intraepithelial lesion (LSIL) or Atypical Squamous Cells of Undetermined Significanc (ASCUS) (for which, as per the recommendation of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)/Italian Group of Cervical Cancer. Screening (GISCI), no treatment is indicated but only follow-up with Human papillomavirus (HPV) test at 12 months.
- Women aged 18-64 who independently perform a positive High risk sub-types of HPV (HR-HPV) test outside of screening even in the presence of a negative cytology (for whom, as per the recommendation of the SICPCV, no treatment is indicated but only follow-up with HPV test at 12 months).
- Women aged 30-64 years HPV HR positive with negative cytology or with positive cytology for ASCUS or LSIL but negative colposcopy (absence of colposcopic lesion or positive colposcopy but subsequent negative biopsy) who do not require treatment (therefore as per the recommendation of the SICPCV go to follow-up with HPV testing at 12 months).
Key exclusion criteria (7 listed)
- Women who have been vaccinated for HPV.
- Patients who have undergone cervical treatments for preneoplastic pathology.
- Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) cytological result who on histological examination after biopsy need treatment according to the SICPCV 2019 recommendations.
- Hypersensitivity to one or more components of the product.
- Patients being treated with antibiotic, immunomodulatory and immunosuppressive therapies.
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 |
|---|---|---|
| Crispact®Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247 | Dietary supplement | Probiotic Lady Group (Women aged 30-64 years), Probiotic Young Group (Women aged 18-29 years) |
| PlaceboPlacebo | Dietary supplement | Control Lady Group (Women aged 18-29 years), Control Young Group (Women aged 18-29 years) |
Primary outcome
Human papillomavirus (HPV) clearance
Time frame: After 4-months
Testing negative for HPV
Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)
Time frame: After 4-months
Changes in vaginal microbiota
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- 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.
Dr. Amjad Khan, DPhil contact
Questions about this trial
What is this clinical trial studying?
A study testing Crispact® in people with Human Papillomavirus Infection, run by Liaquat University of Medical & Health Sciences.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Dr. Amjad Khan, DPhil (+92 333 05069552, amjadkhan@lumhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human papillomavirus (HPV) clearance (time frame: After 4-months). The study lists 2 primary outcomes in all. 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 7 Feb 2024.