Pelvic Organ ProlapseNCT04118049
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment
A study testing BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel. in people with Pelvic Organ Prolapse and Inflammatory Response, run by Hartford Hospital at 1 site in United States.
Trial summary
In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment… Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Inflammatory Response, Dysbiosis
- What is being tested?
- BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 30 May 2021
- 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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal (no menstruation >12 months)
- Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment
- Planning on continuing to use a pessary for treatment for at least 3 months
- Pessary maintenance performed by provider (as opposed to self-care)
- Able to understand English
- Able/willing to sign informed consent document
Who cannot join
- Lack of cognitive ability to consent to participate in study and to complete the questionnaires
- Planned prolapse surgery less than 3 months from enrollment
- Presence of vaginal fistulas
- Pessary self-care (patient changes and cleans her own pessary)
- Receiving immunosuppressive therapy or history of immunodeficiency
- Presence of an indwelling vascular access line or structural heart disease
Show all 10Show fewer
- Within 6 weeks from any abdominal or pelvic surgery or other major surgery
- Allergy to lactobacillus (contents of probiotic)
- Allergy to beta-lactam antibiotics, erythromycin and clindamycin
- Use of any probiotic pills, creams, or suppositories currently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.
In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).
- Conditions
- Pelvic Organ Prolapse, Inflammatory Response, Dysbiosis
- Being tested
- BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel., Standard Care
- Keywords
- Pessary use, Probiotics, Cytokines, Microenvironment
- Medical subject headings
- Pelvic Organ Prolapse, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.Other
BiopHreshTM is a vaginal probiotic supplement that is offered over the counter and contains four different lactobacilli strains (L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus). RestoreTM is a moisturizing personal lubricant that has been on the market for three years. Participants will use 1 probiotic capsule with RestoreTM gel nightly three times weekly.
Standard CareOther
Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Probiotic Arm | Experimental | BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) is offered over the counter. It contains a total of 5 billion lactobacilli: L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus.
RestoreTM gel: moisturizing personal lubricant.
We will recommend to participants to use the probiotic supplement and vaginal lubricant as a vaginal suppository three times weekly at night for 3 months. Receives: Other: BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel. |
| Standard Care Arm | Other | Women will perform standard care which includes follow up at 3 months for pessary removal/care. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vaginal microenvironment
Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.
Measured: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.
Secondary outcomes (6)
Pelvic Floor Disability Index (PFDI-20)
The PFDI-20 will be used in order to evaluate pelvic floor symptoms.
Measured: Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.
Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.
Unvalidated questionnaires (vaginal products and hromonal therapy questionnaire, subjective vaginal experiences over the past month questionnaire, and a vaginal probiotic questionnaire) were created in order to evaluate participant experiences with vaginal probiotics including feasibility, impact on symptoms from pessary use, and side effects from use. These questionnaires do not have scales.
Measured: Participants will complete after 1 month of use as well as at 3 months.
Urinary tract infection incidence
Occurrences of urinary tract infections during the study period will be monitored.
Measured: During participant involvement in the study 3-4 months.
BVAB-1
Evaluate the incidence of BVAB-1 and impact of vaginal probiotics on BVAB-1 in postmenopausal women via gram stain.
Measured: Vaginal specimen will collect from participants upon enrollment and after 3 months.
Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)
Pro-inflammatory cytokines will be evaluated from vaginal specimens collected in order to evaluate (1) the impact of probiotics on the inflammatory environment of the vagina (2) longitudinal assessment of pro-inflammatory cytokines in pessary wearing patients.
Measured: Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months
Incidence of adverse events (safety and tolerability)
number of adverse events (vaginal irritation)
Measured: from enrollment to 3 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start30 Oct 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the treatment arm versus standard care arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, University of Connecticut
- Responsible party
- Sponsor
- Investigators
- Elisabeth Sappenfield, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118049
- Sponsor's protocol ID
- R-HHC-2019-0069
- Status last verified
- Mar 2022
- First submitted
- 1 Oct 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sappenfield EC, Mellen C, Wilcox J, O'Hanlon DE, O'Sullivan DM, Tunitsky-Bitton E. The Impact of Vaginal Probiotics on Pessary Use: A Randomized Controlled Trial. Urogynecology (Phila). 2024 Jan 1;30(1):50-58. doi: 10.1097/SPV.0000000000001379. Epub 2023 Jul 18.
PubMed 37493229
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04118049
- Acronym / sponsor ID
- R-HHC-2019-0069
- Conditions
- Pelvic Organ Prolapse, Inflammatory Response, Dysbiosis
- Keywords
- Pessary use, Probiotics, Cytokines, Microenvironment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- University of Maryland, University of Connecticut
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 7 Oct 2019 (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.
In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to the treatment arm versus standard care arm.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Probiotic Arm | Experimental | Other: BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) is offered over the counter. It contains a total of 5 billion lactobacilli: L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus. RestoreTM gel: moisturizing personal lubricant. We will recommend to participants to use the probiotic supplement and vaginal lubricant as a vaginal suppository three times weekly at night for 3 months. |
| Standard Care Arm | Other | Other: Standard CareWomen will perform standard care which includes follow up at 3 months for pessary removal/care. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal (no menstruation >12 months)
- Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment
- Planning on continuing to use a pessary for treatment for at least 3 months
- Pessary maintenance performed by provider (as opposed to self-care)
- Able to understand English
Key exclusion criteria (10 listed)
- Lack of cognitive ability to consent to participate in study and to complete the questionnaires
- Planned prolapse surgery less than 3 months from enrollment
- Presence of vaginal fistulas
- Pessary self-care (patient changes and cleans her own pessary)
- Receiving immunosuppressive therapy or history of immunodeficiency
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 |
|---|---|---|
| BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.BiopHreshTM is a vaginal probiotic supplement that is offered over the counter and contains four different lactobacilli strains (L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus). RestoreTM is a moisturizing personal lubricant that has been on the market for three years. Participants will use 1 probiotic capsule with RestoreTM gel nightly three times weekly. | Other | Vaginal Probiotic Arm |
| Standard CareStandard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider. | Other | Standard Care Arm |
Primary outcome
Change in vaginal microenvironment
Time frame: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.
Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.
6 secondary outcomes
Pelvic Floor Disability Index (PFDI-20)
Time frame: Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.
Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.
Time frame: Participants will complete after 1 month of use as well as at 3 months.
Urinary tract infection incidence
Time frame: During participant involvement in the study 3-4 months.
BVAB-1
Time frame: Vaginal specimen will collect from participants upon enrollment and after 3 months.
Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)
Time frame: Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months
Incidence of adverse events (safety and tolerability)
Time frame: from enrollment to 3 month follow up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 37493229Sappenfield EC, Mellen C, Wilcox J, O'Hanlon DE, O'Sullivan DM, Tunitsky-Bitton E. The Impact of Vaginal Probiotics on Pessary Use: A Randomized Controlled Trial. Urogynecology (Phila). 2024 Jan 1;30(1):50-58. doi: 10.1097/SPV.0000000000001379. Epub 2023 Jul 18.
- 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.
Elisabeth Sappenfield, MD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel. in people with Pelvic Organ Prolapse and Inflammatory Response, run by Hartford Hospital at 1 site in United States.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 25 Mar 2022. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaginal microenvironment (time frame: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.). 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 NCT04118049, which also lists 1 linked publication.
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 25 Mar 2022.