Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

NCT04118049 | Completed DMC

• 1 other identifier: R-HHC-2019-0069
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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 (cytokines).

Conditions

Pelvic Organ Prolapse; Inflammatory Response; Dysbiosis

Keywords

Pessary use; Probiotics; Cytokines; Microenvironment

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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.

  Participants will complete after 1 month of use as well as at 3 months.

• Urinary tract infection incidence

  During participant involvement in the study 3-4 months.

• BVAB-1

  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)

  Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months

Study Arms (2)

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.

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.

Other: Standard Care

Interventions

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.

Vaginal Probiotic Arm

Standard Care OTHER

Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Standard Care Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• University of Maryland: collaborator
• University of Connecticut: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06103, United States

Location

Related Publications (1)

• 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.

  PMID: 37493229 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Dysbiosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elisabeth Sappenfield, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators performing vaginal specimens are blinded to treatment arm.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the treatment arm versus standard care arm.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 7, 2019
• Study Start: October 30, 2019
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)