FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3)

NCT05850078 | Completed

• 1 other identifier: Dyscover-3
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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 quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab sample.

Conditions

Vaginal Flora Imbalance

Outcome Measures

Primary Outcomes (1)

• Changes in relative abundance of vaginal lactobacilli species

  The change in vaginal microbiome of the active arm participants (FB101 and diluted FB101) versus placebo participants in terms of the combined relative abundance of the vaginal Lactobacillus species crispatus, gasseri and jensenii measured by metagenomic sequencing of vaginal samples.

  from baseline to 2 months after first dose

Study Arms (3)

FB101

EXPERIMENTAL

Microbial intervention using product FB101

Other: FB101

FB101 diluted

EXPERIMENTAL

Microbial intervention using diluted FB101

Other: FB101

Placebo

PLACEBO COMPARATOR

Saline water

Other: FB101

Interventions

FB101 OTHER

Intervention will test effects on changes to the vaginal microbiome of FB101 versus diluted FB101 versus placebo

FB101; FB101 diluted; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able and willing to give written informed consent.
• Age between ≥18 to ≤45.
• Be generally healthy, as determined by the investigator.
• Be a pre-menopausal woman.
• Meet the following definition of vaginal dysbiosis: combined copy number of Lactobacillus species crispatus, gasseri, and jensenii measured by qPCR, corresponding to less than 10% total relative abundance of Lactobacillus species crispatus, gasseri, and jensenii as measured by metagenomic sequencing.
• Have regular, predictable menstrual cycles of known length or have been amenorrhoeic for at least 3 months due to use of a long-acting progestin or hormonal contraceptives.
• Be willing to be asked questions about personal medical, sexual, and behavioural history.
• Be willing to undergo two vaginal microbiome transplant procedures.
• Be willing to self-collect cervicovaginal secretions and vaginal swab samples.
• Be willing to use one of the following effective methods of contraception throughout the clinical study:
• Complete abstinence from vaginal intercourse.
• Have a male sexual partner who is surgically sterilised prior to the screening visit and is the only male sexual partner for that participant.
• Mechanical barrier (condom or diaphragm), or hormone contraception (contraceptive pill, injections, implant or patch).
• Be willing to completely abstain from vaginal intercourse and receptive oral sex during the eight days from visit 4 (first FB101 dose) to visit 6 (first follow-up).
• Be willing to abstain from vaginal intercourse, unless using condoms free from adjunctive spermicide or lubricant (with a male partner) or dental dams (with a female partner), and receptive oral sex, unless using dental dams, in the time period between visit 3 and visit 8.

You may not qualify if:

• Participants who are post-menopausal, defined as more than 12 consecutive months of amenorrhea without another known cause than use of long-acting progestin or hormonal contraceptives.
• Participants who are pregnant, breastfeeding and/or have been pregnant within the last two months.
• Users of any hormonal or non-hormonal intrauterine device (IUD).
• Participants who have HIV/AIDS or other immunodeficiency.
• Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma genitalium, and/or Trichomonas vaginalis. Potential participants may be re-screened if they receive successful treatment at their own medical provider.
• Participants who have received treatment involving experimental drugs less than 30 days prior to this study.
• Participants who have undergone some sort of procedure involving trauma to the cervix within the last month prior to screening (i.e., IUD removal, cervical cryotherapy, or cervical laser treatment).
• Participants with any known condition requiring regular use of antibiotics, that would suggest the participant is likely to require antibiotic treatment during the study.
• Systemic and/or vaginally applied antibiotic use within the last month prior to screening.
• Participants with new (\<3 months) use of long-acting hormonal treatments. Participant may be enrolled if stable (\>3 months) or existing therapy as determined by the investigator.
• Participants with any social, medical, or psychiatric condition that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.
• Participants with a history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.
• Participants with a history of gynaecological cancers, gynaecological conditions, or surgical gynaecological medical history, which, in the opinion of the investigator, precludes participation.
• Participants with abnormal finding on screening examination, which, in the opinion of the investigator, precludes participation.
• Participants with clinically relevant abnormalities in the cervix or uterine cavity that could interfere with the collection of endometrial fluid.

Sponsors & Collaborators

• Freya Biosciences ApS: lead

Study Sites (1)

Atlantia Clinical Trials

Cork, Ireland

Location

Study Officials

• Fergus McCarthy, PhD, MD

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, clinical investigators as well as outcome assessors (laboratories) will be blinded to treatment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, parallel, 3-arm, placebo-controlled study.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: May 18, 2023
• Primary Completion: August 29, 2024
• Study Completion: January 24, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)