Bacterial VaginosisPhase 1NCT05587283
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women
A Phase 1 study testing Experimental: Low dose LABTHERA-001 capsule, Experimental: Medium dose LABTHERA-001 capsule and Experimental: High dose LABTHERA-001 capsule in people with Bacterial Vaginosis and Vaginal Disease, run by AtoGen Co. Ltd at 1 site in Australia.
Trial summary
This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Vaginal Disease, Bacterial Infections
- What is being tested?
- Experimental: Low dose LABTHERA-001 capsule, Experimental: Medium dose LABTHERA-001 capsule and Experimental: High dose LABTHERA-001 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Nov 2022to May 2023
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-smoking woman aged 18 to 45 years old as of the date of written consent
- Agrees to maintain her contraceptive method during the clinical trial if she has regular menstrual cycles (21-35 days) or has had amenorrhea for more than 12 weeks before the Screening Visit due to continued use of long-acting progestin or oral contraceptives.
- Confirmed normal cervical screen test (CST) performed at the Screening Visit
- Has had sexual experiences that included vaginal intercourse
- Has experienced gynecological examinations previously
- Agrees to discontinue the use of the following during the clinical trial period (Screening Visit to End of study visit or early termination visit):
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- products for vaginal insertion (e.g., tampons, menstrual cups, etc.)
- Other vaginal products (e.g., contraceptive creams, vaginal cleaners, lubricants, etc.)
- Agrees to be sexually abstinent from 72 hours before the Day 1 visit until the first study visit after final administration of IP (nominally the Day 9 visit).
- Agrees to continue to use the following highly effective contraceptive methods during the clinical trial period and for at least 30 days after the final dose of study treatment, if woman of child-bearing potential (has experienced menarche and is not permanently sterile or postmenopausal):
- Female: combined (estrogen and progestogen containing) hormonal/ contraception associated with inhibition of ovulation (oral or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD; if inserted more than 12 weeks before the Screening visit), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence
- Male partner: 'Vasectomy,' 'condom'
- Able and willing to insert a hard capsule into her vagina
- Able and willing to answer questions about her health status and sexual life
- Able and willing to undergo vaginal and cervical examinations by the Investigator
- Agrees and can comply with the planned clinical trial procedures after receiving a full explanation and voluntarily decides to participate and gives written informed consent
Who cannot join
- Confirmed to have the following urogenital infections from the vaginal discharge test performed at the Screening Visit, or had the following diagnosed urogenital infections within three weeks before the Screening Visit, or has a history of clinically significant urogenital infections at the discretion of the Investigator:
- Urinary tract infection, bacterial vaginosis, candida vaginitis, trichomonas vaginalis, Neisseria gonorrhoeae, chlamydia trachomatis, treponema pallidum, herpes simplex
- History of recurrent genital herpes
- Has the following diagnosed urogenital infections, or had two or more clinically significant urogenital infections within 24 weeks before the Screening Visit, at the discretion of the Investigator:
- [Gonococcus, chlamydia trachomatis, syphilis treponema, trichomonas vaginitis, candida vaginitis, etc.]
- Has vaginitis symptoms (abnormal vaginal discharge, itching, burning sensation, etc.) at Screening or pre-dose at the Day 1 visit, or between the Screening and Day 1 visits.
Show all 24Show fewer
- Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancy within 60 days of the last dose of IP.
- Is menopausal, defined as being amenorrhoeic for at least 12 months without an alternative cause.
- Has had an intrauterine device (IUD) inserted within 12 weeks before the Screening Visit
- Underwent pelvic surgery within 12 weeks before the Screening Visit
- Received cervical cryotherapy or cervical laser treatment within 12 weeks before the Screening Visit
- Started to use long-acting hormonal contraceptives within 12 weeks before the Screening Visit [e.g., DMPA (depot formulation including medroxyprogesterone acetate)] (However, participants who have continuously used the contraceptive for more than 12 weeks can be enrolled at the discretion of the Investigator.)
- Has a clinically significant medical history or current medical condition as assessed by the Investigator including but not limited to the cardiovascular system, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, psychiatric disorder, or infectious disease, that may affect the safety evaluation of the investigational product or jeopardize the individual's involvement in the study. History of any cancer (including non-melanoma skin cancer) is exclusionary.
- Positive test for SARS-CoV-2 (COVID-19) during the Screening period and pre-dose at the Day 1 visit (may be re-screened when eligible).
- Positive diagnosis of human immunodeficiency virus (HIV), hepatitis B or C at the Screening Visit
- Confirmed to have severe damage to the vaginal epithelium in the physical examination at the Screening Visit
- Used immunosuppressants within four weeks before the Screening Visit
- Used antibiotics or antifungals within three days before the Screening Visit (However, enrollment is possible if the individual agrees to a washout period equivalent to three times or more the half-life of the corresponding drugs as of the randomization date.)
- History of hypersensitivity reactions to the components of the study drug or history of other serious drug hypersensitivity reactions, at the discretion of the Investigator
- History of or current drug or alcohol abuse; or tests positive to urine drug screen or alcohol breath test at the Screening or Day 1 visits; or does not agree to abstain from alcohol 24 hours before each study visit and to consume no more than 10 standard drinks per week with no more than 4 standard drinks on any one day at any other time during their participation in the study. One standard drink contains 10 g alcohol. Urine drug screen may be repeated once only at the discretion of the Investigator.
- Current tobacco smoker; or smoked more than one pack of cigarettes (or tobacco equivalent) per day for more than 10 years; or uses nicotine-replacement therapy (including vaping); or does not agree to abstain from using tobacco or nicotine-containing products during the study.
- Received other investigational products within four weeks before the Screening Visit
- Received COVID-19 vaccination or any other vaccination within 8 weeks before the first dose of IP, and/or is planning or scheduled to be vaccinated (including COVID-19 initial, second or booster dose) during the study period up to the final follow-up visit.
- Judged by the Investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
Scientia Clinical Research Study Team contact
Australia1 site, 1 recruiting
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
Christopher Argent, Dr., +61 02 9382 5800, christopher.argent@scientiaclinicalresearch.com.au
About this study
Official title: Phase 1 Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability and Acceptability of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Female Volunteers
This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.
Read the detailed description
Bacterial vaginosis (BV) is the most common vaginal syndrome frequently found in women. BV is currently mainly treated with antibiotics. However, antibiotic administration can cause various side effects. And one of them is destroying the normal bacteria in the vagina, affecting the balance of the vaginal flora, increasing the likelihood of bacterial vaginosis recurrence, and causing drug resistance of bacteria. Therefore, the importance of fundamental treatment with the recovery of balance in normal vaginal flora is being recognized increasingly. The study drug for this trial, LABTHERA-001, has been derived from the bacteria Lactobacillus plantarum ATG-K2. Administration of the ATG-K2 strain will temporarily colonize the vagina to encourage a more normal microbiome.
The main goals of this study are 1. to determine whether LABTHERA-001 is safe and well tolerated in healthy adult women. And 2. to investigate the acceptability of the LABTHERA-001 capsule or matching placebo by completing a satisfaction evaluation questionnaire.
- Conditions
- Bacterial Vaginosis, Vaginal Disease, Bacterial Infections, Vaginitis, Infection, Bacterial
- Being tested
- Experimental: Low dose LABTHERA-001 capsule, Experimental: Medium dose LABTHERA-001 capsule, Experimental: High dose LABTHERA-001 capsule, Placebo Comparator: Low dose Placebo capsule, Placebo Comparator: Medium dose Placebo capsule
- Keywords
- LBP
- Medical subject headings
- Vaginosis, Bacterial, Vaginal Diseases, Bacterial Infections, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Low dose LABTHERA-001 capsuleDrug
Also called Lactobacillus Plantarum ATG-K2
Low dose LABTHERA-001 capsule, 0.2 x 10^9 CFU/capsule with excipients.
Experimental: Medium dose LABTHERA-001 capsuleDrug
Also called Lactobacillus Plantarum ATG-K2
Medium dose LABTHERA-001 capsule, 1 x 10^9 CFU/capsule with excipients.
Experimental: High dose LABTHERA-001 capsuleDrug
Also called Lactobacillus Plantarum ATG-K2
High dose LABTHERA-001 capsule, 5 x 10^9 CFU/capsule with excipients.
Placebo Comparator: Low dose Placebo capsuleOther
Also called Control substance
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Placebo Comparator: Medium dose Placebo capsuleOther
Also called Control substance
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Placebo Comparator: High dose Placebo capsuleOther
Also called Control substance
High dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
| Study group | Role | What they receive |
|---|---|---|
| Low dose LABTHERA-001 capsule | Experimental | Low dose LABTHERA-001 capsule (0.2 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days. Receives: Drug: Experimental: Low dose LABTHERA-001 capsule |
| Medium dose LABTHERA-001 capsule | Experimental | Medium dose LABTHERA-001 capsule (1 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days. Receives: Drug: Experimental: Medium dose LABTHERA-001 capsule |
| High dose LABTHERA-001 capsule | Experimental | High dose LABTHERA-001 capsule (5 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days. Receives: Drug: Experimental: High dose LABTHERA-001 capsule |
| Low dose Placebo capsule | Placebo comparator | Low dose Placebo (excipients of the study drug) capsule administered intravaginally once a day for 7 consecutive days. Receives: Other: Placebo Comparator: Low dose Placebo capsule |
| Medium dose Placebo capsule | Placebo comparator | Medium dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days. Receives: Other: Placebo Comparator: Medium dose Placebo capsule |
| High dose Placebo capsule | Placebo comparator | High dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days. Receives: Other: Placebo Comparator: High dose Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AEs in participants throughout the study and their severity and relationship to the study product.
Any incidence of adverse events will be evaluated for their severity and relationship to the study product. The number of AEs and other combined measurement results will be evaluated for the safety of the study product.
Measured: 35 days since the first dose administration
Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination.
Day 1 pre-dose results will be used as the baseline values. Abnormalities in clinical laboratory parameters, gynaecological examination findings, and vital signs will be based on predefined normal ranges and will be tabulated by dose group showing participant counts and percentages.
Measured: Baseline and each follow-up visit upto 35 days since the first dose administration (Day 1)
Secondary outcomes (1)
Acceptability evaluation
5-point Likert scale, 1 (strongly disagree), 2 (disagree), 3 (neither disagree or agree), 4 (agree), and 5 (strongly agree), in response to 7 statements at visit 3 (Day 9) to evaluate how acceptable participants found using the study product.
Measured: Visit 3 (Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start2 Nov 2022
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eight participants will be randomized to be allocated into either a treatment group or a placebo control group (3:1 ratio) for each cohort. There will be three ascending dose cohorts. For the first two doses, the next dose cohorts will begin enrollment only after the safety data review meets a satisfactory evaluation by the safety review committee.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AtoGen Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ATOGEN AUSTRALIA PTY LTD
- Responsible party
- Sponsor
- Investigators
- Christopher Argent, Dr., Principal investigator, Scientia Clinical Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587283
- Sponsor's protocol ID
- LT-001
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mastromarino P, Vitali B, Mosca L. Bacterial vaginosis: a review on clinical trials with probiotics. New Microbiol. 2013 Jul;36(3):229-38. Epub 2013 Jun 30.
PubMed 23912864Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol. 2013 Dec;209(6):505-23. doi: 10.1016/j.ajog.2013.05.006. Epub 2013 May 6.
PubMed 23659989Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
PubMed 34292926Vicariotto F, Mogna L, Del Piano M. Effectiveness of the two microorganisms Lactobacillus fermentum LF15 and Lactobacillus plantarum LP01, formulated in slow-release vaginal tablets, in women affected by bacterial vaginosis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S106-12. doi: 10.1097/MCG.0000000000000226.
PubMed 25291116De Seta F, Parazzini F, De Leo R, Banco R, Maso GP, De Santo D, Sartore A, Stabile G, Inglese S, Tonon M, Restaino S. Lactobacillus plantarum P17630 for preventing Candida vaginitis recurrence: a retrospective comparative study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:136-9. doi: 10.1016/j.ejogrb.2014.09.018. Epub 2014 Sep 17.
PubMed 25305660Strus M, Chmielarczyk A, Kochan P, Adamski P, Chelmicki Z, Chelmicki A, Palucha A, Heczko PB. Studies on the effects of probiotic Lactobacillus mixture given orally on vaginal and rectal colonization and on parameters of vaginal health in women with intermediate vaginal flora. Eur J Obstet Gynecol Reprod Biol. 2012 Aug;163(2):210-5. doi: 10.1016/j.ejogrb.2012.05.001. Epub 2012 Jun 19.
PubMed 22721635Hemalatha R, Mastromarino P, Ramalaxmi BA, Balakrishna NV, Sesikeran B. Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study. Eur J Clin Microbiol Infect Dis. 2012 Nov;31(11):3097-105. doi: 10.1007/s10096-012-1671-1. Epub 2012 Jul 10.
PubMed 22777592
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability and Acceptability of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT05587283
- Acronym / sponsor ID
- LT-001
- Conditions
- Bacterial Vaginosis, Vaginal Disease, Bacterial Infections, Vaginitis, Infection, Bacterial
- Keywords
- LBP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AtoGen Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- ATOGEN AUSTRALIA PTY LTD
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Oct 2022 (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 is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.
Detailed description
Bacterial vaginosis (BV) is the most common vaginal syndrome frequently found in women. BV is currently mainly treated with antibiotics. However, antibiotic administration can cause various side effects. And one of them is destroying the normal bacteria in the vagina, affecting the balance of the vaginal flora, increasing the likelihood of bacterial vaginosis recurrence, and causing drug resistance of bacteria. Therefore, the importance of fundamental treatment with the recovery of balance in normal vaginal flora is being recognized increasingly. The study drug for this trial, LABTHERA-001, has been derived from the bacteria Lactobacillus plantarum ATG-K2. Administration of the ATG-K2 strain will temporarily colonize the vagina to encourage a more normal microbiome.
The main goals of this study are 1. to determine whether LABTHERA-001 is safe and well tolerated in healthy adult women. And 2. to investigate the acceptability of the LABTHERA-001 capsule or matching placebo by completing a satisfaction evaluation questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Eight participants will be randomized to be allocated into either a treatment group or a placebo control group (3:1 ratio) for each cohort. There will be three ascending dose cohorts. For the first two doses, the next dose cohorts will begin enrollment only after the safety data review meets a satisfactory evaluation by the safety review committee.
| Arm | Type | Receives |
|---|---|---|
| Low dose LABTHERA-001 capsule | Experimental | Drug: Experimental: Low dose LABTHERA-001 capsuleLow dose LABTHERA-001 capsule (0.2 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days. |
| Medium dose LABTHERA-001 capsule | Experimental | Drug: Experimental: Medium dose LABTHERA-001 capsuleMedium dose LABTHERA-001 capsule (1 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days. |
| High dose LABTHERA-001 capsule | Experimental | Drug: Experimental: High dose LABTHERA-001 capsuleHigh dose LABTHERA-001 capsule (5 x 10^9 CFU), administered intravaginally once a day for 7 consecutive days. |
| Low dose Placebo capsule | Placebo comparator | Other: Placebo Comparator: Low dose Placebo capsuleLow dose Placebo (excipients of the study drug) capsule administered intravaginally once a day for 7 consecutive days. |
| Medium dose Placebo capsule | Placebo comparator | Other: Placebo Comparator: Medium dose Placebo capsuleMedium dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days. |
| High dose Placebo capsule | Placebo comparator | Other: Placebo Comparator: High dose Placebo capsuleHigh dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy non-smoking woman aged 18 to 45 years old as of the date of written consent
- Agrees to maintain her contraceptive method during the clinical trial if she has regular menstrual cycles (21-35 days) or has had amenorrhea for more than 12 weeks before the Screening Visit due to continued use of long-acting progestin or oral contraceptives.
- Confirmed normal cervical screen test (CST) performed at the Screening Visit
- Has had sexual experiences that included vaginal intercourse
- Has experienced gynecological examinations previously
Key exclusion criteria (24 listed)
- Confirmed to have the following urogenital infections from the vaginal discharge test performed at the Screening Visit, or had the following diagnosed urogenital infections within three weeks before the Screening Visit, or has a history of clinically significant urogenital infections at the discretion of the Investigator:
- History of recurrent genital herpes
- Has the following diagnosed urogenital infections, or had two or more clinically significant urogenital infections within 24 weeks before the Screening Visit, at the discretion of the Investigator:
- Has vaginitis symptoms (abnormal vaginal discharge, itching, burning sensation, etc.) at Screening or pre-dose at the Day 1 visit, or between the Screening and Day 1 visits.
- Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancy within 60 days of the last dose of IP.
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 |
|---|---|---|
| Experimental: Low dose LABTHERA-001 capsuleAlso: Lactobacillus Plantarum ATG-K2Low dose LABTHERA-001 capsule, 0.2 x 10^9 CFU/capsule with excipients. | Drug | Low dose LABTHERA-001 capsule |
| Experimental: Medium dose LABTHERA-001 capsuleAlso: Lactobacillus Plantarum ATG-K2Medium dose LABTHERA-001 capsule, 1 x 10^9 CFU/capsule with excipients. | Drug | Medium dose LABTHERA-001 capsule |
| Experimental: High dose LABTHERA-001 capsuleAlso: Lactobacillus Plantarum ATG-K2High dose LABTHERA-001 capsule, 5 x 10^9 CFU/capsule with excipients. | Drug | High dose LABTHERA-001 capsule |
| Placebo Comparator: Low dose Placebo capsuleAlso: Control substanceMedium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate. | Other | Low dose Placebo capsule |
| Placebo Comparator: Medium dose Placebo capsuleAlso: Control substanceMedium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate. | Other | Medium dose Placebo capsule |
| Placebo Comparator: High dose Placebo capsuleAlso: Control substanceHigh dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate. | Other | High dose Placebo capsule |
Primary outcome
Number of AEs in participants throughout the study and their severity and relationship to the study product.
Time frame: 35 days since the first dose administration
Any incidence of adverse events will be evaluated for their severity and relationship to the study product. The number of AEs and other combined measurement results will be evaluated for the safety of the study product.
Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination.
Time frame: Baseline and each follow-up visit upto 35 days since the first dose administration (Day 1)
Day 1 pre-dose results will be used as the baseline values. Abnormalities in clinical laboratory parameters, gynaecological examination findings, and vital signs will be based on predefined normal ranges and will be tabulated by dose group showing participant counts and percentages.
1 secondary outcome
Acceptability evaluation
Time frame: Visit 3 (Day 9)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 23912864Mastromarino P, Vitali B, Mosca L. Bacterial vaginosis: a review on clinical trials with probiotics. New Microbiol. 2013 Jul;36(3):229-38. Epub 2013 Jun 30.
- Background: PubMed 23659989Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol. 2013 Dec;209(6):505-23. doi: 10.1016/j.ajog.2013.05.006. Epub 2013 May 6.
- Background: PubMed 34292926Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
- Background: PubMed 25291116Vicariotto F, Mogna L, Del Piano M. Effectiveness of the two microorganisms Lactobacillus fermentum LF15 and Lactobacillus plantarum LP01, formulated in slow-release vaginal tablets, in women affected by bacterial vaginosis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S106-12. doi: 10.1097/MCG.0000000000000226.
- Background: PubMed 25305660De Seta F, Parazzini F, De Leo R, Banco R, Maso GP, De Santo D, Sartore A, Stabile G, Inglese S, Tonon M, Restaino S. Lactobacillus plantarum P17630 for preventing Candida vaginitis recurrence: a retrospective comparative study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:136-9. doi: 10.1016/j.ejogrb.2014.09.018. Epub 2014 Sep 17.
- Background: PubMed 22721635Strus M, Chmielarczyk A, Kochan P, Adamski P, Chelmicki Z, Chelmicki A, Palucha A, Heczko PB. Studies on the effects of probiotic Lactobacillus mixture given orally on vaginal and rectal colonization and on parameters of vaginal health in women with intermediate vaginal flora. Eur J Obstet Gynecol Reprod Biol. 2012 Aug;163(2):210-5. doi: 10.1016/j.ejogrb.2012.05.001. Epub 2012 Jun 19.
- Background: PubMed 22777592Hemalatha R, Mastromarino P, Ramalaxmi BA, Balakrishna NV, Sesikeran B. Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study. Eur J Clin Microbiol Infect Dis. 2012 Nov;31(11):3097-105. doi: 10.1007/s10096-012-1671-1. Epub 2012 Jul 10.
- 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.
Scientia Clinical Research Study Team contact
Christopher Argent, Dr. principal investigator
Scientia Clinical Research Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental: Low dose LABTHERA-001 capsule, Experimental: Medium dose LABTHERA-001 capsule and Experimental: High dose LABTHERA-001 capsule in people with Bacterial Vaginosis and Vaginal Disease, run by AtoGen Co. Ltd at 1 site in Australia.
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 16 inclusion and 24 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 9 Mar 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 Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Scientia Clinical Research Study Team (+61 02 9382 5800, christopher.argent@scientiaclinicalresearch.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of AEs in participants throughout the study and their severity and relationship to the study product. (time frame: 35 days since the first dose administration). 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?
On the ClinicalTrials.gov record for NCT05587283, which also lists 7 linked publications.
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 9 Mar 2023.