Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome

NCT05701722 | Completed FDA Device

• 1 other identifier: BV30123
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are:

• Does using a specific vaginal care system reduce recurrence of BV?
• How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will:
• Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study
• Answer questionnaires about vulvovaginal symptoms at each of these three timepoints
• Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.

Conditions

Bacterial Vaginosis

Keywords

vaginal microbiome; vaginal pH; Probiotic; Lactobacillus

Outcome Measures

Primary Outcomes (1)

• Recurrence of bacterial vaginosis (BV)

  The number of separate BV episodes will be assessed between baseline and 24 weeks in each arm separately. BV may be diagnosed by clinical test (Aptima, SureSwab, Affirm VPIII, etc.) that is routinely used by the study site; Amsel criteria; and/or Nugent scores. Where there is discordance between tests, the participant will be BV positive if 2/3 tests are positive. BV positive by Amsel criteria include having at least 3 of the following 4 parameters: 1) thin, white-to-gray homogeneous vaginal discharge; 2) amine odor upon addition of a drop of 10% KOH to vaginal fluid on a slide; 3) vaginal pH greater than 4.5; 4) more than 20% of epithelial cells being clue cells on a vaginal smear slide. Nugent scoring is based on a Gram stain of vaginal fluid smear, with scores of 1-3 being healthy, 4-6 being intermediate; and 7-10 being positive for BV (unhealthy). Note that not all sites may perform Amsel and/or Nugent scoring.

  24 week duration of the study

Secondary Outcomes (5)

• Vaginal pH changes

  Baseline, 12 weeks, and 24 weeks will be compared using repeated measures two-way ANOVA with study arm and time as factors.

• Vaginal microbiome whole-genome sequencing changes

  Baseline to 24 weeks

• Vaginal microbiome whole-genome sequencing changes

  Baseline to 12 weeks

• Vulvovaginal symptoms by questionnaires

  Baseline to 24 weeks

• Vulvovaginal symptoms by questionnaires

  Baseline to 12 weeks

Study Arms (2)

Routine Care

NO INTERVENTION

Women with recurrent BV who are randomly assigned to the Routine Care (control) arm will undergo assessments at baseline, 12 weeks, and 24 weeks. They will be treated with appropriate antibiotics or antifungals in case of BV or yeast infection, respectively, but otherwise will not receive any treatment. They may engage in any vulvovaginal hygiene of their choosing except for using products made by Good Clean Love.

Flourish HEC

EXPERIMENTAL

Women with recurrent BV who are randomly assigned to the Flourish HEC (intervention) arm will undergo assessments at baseline, 12 weeks, and 24 weeks. They will receive routine care as needed (see Routine Care arm). In addition, they will use the Flourish HEC Vaginal Care System regularly for the 24-week duration of the study. Briefly, they will use Balance intimate wash daily with regular bathing; BioNourish vaginal moisturizing gel every other day; and BiopHresh homeopathic vaginal suppository with probiotics every 3rd day. They will use no other products (except menstrual hygiene products) in the vulvovaginal area during the study.

Device: Flourish HEC Vaginal Care System

Interventions

Flourish HEC Vaginal Care System DEVICE

BioNourish, a component of the Flourish HEC system, is a class II medical device. In addition to BioNourish, the system includes Balance intimate wash and BiopHresh homeopathic vaginal suppository with probiotics. All products are available over the counter and have been on the market for several years.

Also known as: BioNourish Vaginal Moisturizing Gel

Flourish HEC

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cis-gender women between ages 18 and 52
• Premenopausal
• Clinically diagnosed with BV twice in the past six months or three times within the past year (by provider-determined criteria)

You may not qualify if:

• Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care System
• Immunosuppressed or otherwise immunocompromised
• Vaginal infection at the start of the study other than bacterial vaginosis or yeast infection (these may be treated prior to starting the protocol)
• Recent (within past 3 months) use of any antibiotics except for treating BV
• Surgery within the past 3 months
• Pregnant or trying to conceive during the trial
• Lactating women
• Recent (within past 3 months) usage of any Good Clean Love® (GCL) products
• Sexual trauma history causing psychiatric or mental health disorders which may be triggered by questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products

Sponsors & Collaborators

• Vaginal Biome Science: lead

Study Sites (1)

Haven Center for Sexual Medicine & Vulvovaginal Disorders

Tulsa, Oklahoma, 74137, United States

Location

Related Publications (15)

• Chidawanyika T, Yi CHC, Kelly-Martin R, Cleland J, DuPriest E. Clinical trial to survey results of Flourish vaginal care system for recurrent BV [A80]. Obstet Gynecol. 2022;139:24S. doi:10.1097/01.AOG.0000826648.49549.01

  BACKGROUND

• O'Hanlon DE, Gajer P, Brotman RM, Ravel J. Asymptomatic Bacterial Vaginosis Is Associated With Depletion of Mature Superficial Cells Shed From the Vaginal Epithelium. Front Cell Infect Microbiol. 2020 Mar 10;10:106. doi: 10.3389/fcimb.2020.00106. eCollection 2020.

  PMID: 32211347 BACKGROUND

• Nagot N, Ouedraogo A, Defer MC, Vallo R, Mayaud P, Van de Perre P. Association between bacterial vaginosis and Herpes simplex virus type-2 infection: implications for HIV acquisition studies. Sex Transm Infect. 2007 Aug;83(5):365-8. doi: 10.1136/sti.2007.024794. Epub 2007 May 10.

  PMID: 17493979 BACKGROUND

• Denney JM, Culhane JF. Bacterial vaginosis: a problematic infection from both a perinatal and neonatal perspective. Semin Fetal Neonatal Med. 2009 Aug;14(4):200-3. doi: 10.1016/j.siny.2009.01.008. Epub 2009 Apr 11.

  PMID: 19362525 BACKGROUND

• Bradshaw CS, Morton AN, Hocking J, Garland SM, Morris MB, Moss LM, Horvath LB, Kuzevska I, Fairley CK. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006 Jun 1;193(11):1478-86. doi: 10.1086/503780. Epub 2006 Apr 26.

  PMID: 16652274 BACKGROUND

• Sobel JD, Schmitt C, Meriwether C. Long-term follow-up of patients with bacterial vaginosis treated with oral metronidazole and topical clindamycin. J Infect Dis. 1993 Mar;167(3):783-4. doi: 10.1093/infdis/167.3.783. No abstract available.

  PMID: 8440952 BACKGROUND

• De Seta F, Campisciano G, Zanotta N, Ricci G, Comar M. The Vaginal Community State Types Microbiome-Immune Network as Key Factor for Bacterial Vaginosis and Aerobic Vaginitis. Front Microbiol. 2019 Oct 30;10:2451. doi: 10.3389/fmicb.2019.02451. eCollection 2019.

  PMID: 31736898 BACKGROUND

• Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.

  PMID: 20534435 BACKGROUND

• Wang Z, He Y, Zheng Y. Probiotics for the Treatment of Bacterial Vaginosis: A Meta-Analysis. Int J Environ Res Public Health. 2019 Oct 12;16(20):3859. doi: 10.3390/ijerph16203859.

  PMID: 31614736 BACKGROUND

• Senok AC, Verstraelen H, Temmerman M, Botta GA. Probiotics for the treatment of bacterial vaginosis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD006289. doi: 10.1002/14651858.CD006289.pub2.

  PMID: 19821358 BACKGROUND

• Hallen A, Jarstrand C, Pahlson C. Treatment of bacterial vaginosis with lactobacilli. Sex Transm Dis. 1992 May-Jun;19(3):146-8. doi: 10.1097/00007435-199205000-00007.

  PMID: 1523530 BACKGROUND

• Reid G, Burton J, Hammond JA, Bruce AW. Nucleic acid-based diagnosis of bacterial vaginosis and improved management using probiotic lactobacilli. J Med Food. 2004 Summer;7(2):223-8. doi: 10.1089/1096620041224166.

  PMID: 15298771 BACKGROUND

• Witkin SS, Mendes-Soares H, Linhares IM, Jayaram A, Ledger WJ, Forney LJ. Influence of vaginal bacteria and D- and L-lactic acid isomers on vaginal extracellular matrix metalloproteinase inducer: implications for protection against upper genital tract infections. mBio. 2013 Aug 6;4(4):e00460-13. doi: 10.1128/mBio.00460-13.

  PMID: 23919998 BACKGROUND

• Ananthapadmanabhan KP, Moore DJ, Subramanyan K, Misra M, Meyer F. Cleansing without compromise: the impact of cleansers on the skin barrier and the technology of mild cleansing. Dermatol Ther. 2004;17 Suppl 1:16-25. doi: 10.1111/j.1396-0296.2004.04s1002.x.

  PMID: 14728695 BACKGROUND

• France MT, Ma B, Gajer P, Brown S, Humphrys MS, Holm JB, Waetjen LE, Brotman RM, Ravel J. VALENCIA: a nearest centroid classification method for vaginal microbial communities based on composition. Microbiome. 2020 Nov 23;8(1):166. doi: 10.1186/s40168-020-00934-6.

  PMID: 33228810 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Corey Babb, DO

  Haven Center for Sexual Medicine & Vulvovaginal Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: March 29, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

US (1)