FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (DYSCOVER-1)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05114031 |
Recruitment Status :
Completed
First Posted : November 9, 2021
Last Update Posted : May 3, 2023
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | October 19, 2021 | ||||
First Posted Date ICMJE | November 9, 2021 | ||||
Last Update Posted Date | May 3, 2023 | ||||
Actual Study Start Date ICMJE | October 20, 2021 | ||||
Actual Primary Completion Date | October 15, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Changes in relative abundance of combined vaginal lactobacilli species [ Time Frame: Comparing baseline (visit 2) to the following time points: 1 (visit 6), 2 (Visit 7), 3 (Visit 8), 4 (Visit 9), 5 (Visit 10) and 6 (Visit 11) months after Baseline ] The change in vaginal microbiome in active FB101 arm versus placebo arm measured as changes in relative abundance of combined vaginal lactobacilli species measured by metagenomic sequencing of vaginal samples.
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | FB101 Intervention in Women Screened to Have Vaginal Dysbiosis | ||||
Official Title ICMJE | FB101 Intervention in Asymptomatic Healthy Volunteers Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Study | ||||
Brief Summary | This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by metagenomic sequencing of a vaginal swab sample. | ||||
Detailed Description | This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by metagenomic sequencing of a vaginal swab sample. A dose of FB101 will be given on 3 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 6 months after the first FD101 dose. The study includes a screening visit where all criteria for participation are checked and a vaginal swab is obtained to check if pre-defined dysbiosis criteria are met based on metagenomic sequencing. If, and when, all criteria are confirmed, a baseline visit, visit 2, is scheduled to be performed around day 8 of the following menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 3(active): 1(placebo) and the first dose is given. At visit 3 and 4 (performed on day 9 and 10 in the same menstrual cycle as Visit 2) the following 2 doses are given. In total, 7 follow-up visits (visit 5-11) are scheduled to occur for a period of up to 6 months after the first dose. All follow-up visits will be scheduled to occur around day 8 in the subject's menstrual cycle with one menstrual cycle in between visits. At follow up visits, close safety monitoring will be performed as well as metagenomic sequencing assessment of the microbiota in a vaginal swab. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomised, double-blind, parallel, 2-arm, placebo-controlled study. Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Subjects, clinical investogators as well as outcome assessors (laboratories) will be blinded to treatment. Primary Purpose: Basic Science
|
||||
Condition ICMJE | Vaginal Flora Imbalance | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
34 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Actual Study Completion Date ICMJE | February 1, 2023 | ||||
Actual Primary Completion Date | October 15, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Ireland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05114031 | ||||
Other Study ID Numbers ICMJE | DYSCOVER-1 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Freya Biosciences ApS | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Freya Biosciences ApS | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Freya Biosciences ApS | ||||
Verification Date | October 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |