Probiotic, Human Papillomavirus Infection, Pap Smear, MicrobiomeNCT06001190
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women
A study testing probiotic:Lactobacillus crispatus in people with Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or HPV positive. After oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome
- What is being tested?
- probiotic:Lactobacillus crispatus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2023to 30 Mar 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 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed as vaginal viginitis
- willing to sign permit
- willing to regular follow up
Who cannot join
- Pregnant
- Virgin
- Severe cervix pathology CINII or CIN III
- Confirmed cervical cancer
- under long term antibiotics due to other physical condition
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Yu-Che Ou, MD, +886-7-732-7123 ext. 8916, tedycou@gmail.com
About this study
A single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or HPV positive. After oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study.
- Being tested
- probiotic:Lactobacillus crispatus
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic:Lactobacillus crispatusDietary supplement
We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.
| Study group | Role | What they receive |
|---|---|---|
| probiotic intervention | Active comparator | probiotic group with daily treatment Receives: Dietary Supplement: probiotic:Lactobacillus crispatus |
| placebo | Placebo comparator | placebo-controlled with daily treatment Receives: Dietary Supplement: probiotic:Lactobacillus crispatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement alteration of vaginal microbiome
16s rRNA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Jul 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Probiotic, Human Papillomavirus Infection, Pap Smear, MicrobiomeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001190
- Sponsor's protocol ID
- CORPG6M0171
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women
- ClinicalTrials.gov ID
- NCT06001190
- Acronym / sponsor ID
- CORPG6M0171
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 21 Aug 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.
A single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or HPV positive. After oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic intervention | Active comparator | Dietary Supplement: probiotic:Lactobacillus crispatusprobiotic group with daily treatment |
| placebo | Placebo comparator | Dietary Supplement: probiotic:Lactobacillus crispatusplacebo-controlled with daily treatment |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed as vaginal viginitis
- willing to sign permit
- willing to regular follow up
Key exclusion criteria (5 listed)
- Pregnant
- Virgin
- Severe cervix pathology CINII or CIN III
- Confirmed cervical cancer
- under long term antibiotics due to other physical condition
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 |
|---|---|---|
| probiotic:Lactobacillus crispatusWe seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study. | Dietary supplement | placebo, probiotic intervention |
Primary outcome
improvement alteration of vaginal microbiome
Time frame: 3 months
16s rRNA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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.
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic:Lactobacillus crispatus in people with Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 21 Aug 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement alteration of vaginal microbiome (time frame: 3 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 21 Aug 2023.