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MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH (MOTIF@FRESH)

14 de mayo de 2026 actualizado por: Douglas Kwon
The MOTIF@ FRESH trial will assess the safety and efficacy of "vaginal microbiome transplantation" (VMT). Healthy females will be enrolled to donate vaginal fluid which will be processed and transplanted in females with a history of recurrent bacterial vaginosis (BV), treated with antibiotics.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The proposed randomized, double-blinded, placebo-controlled trial is to evaluate the safety of vaginal microbiota transplantation (VMT) in women with recurrent bacterial vaginosis (BV). The study is based in South Africa, at the FRESH (Females Rising through Education, Support, and Health) Clinical Research Site (CRS) located in the Umlazi Township of Durban. The aim of the trial is to assess the ability of antibiotic treatment plus VMT to establish a Lactobacillus-dominant vaginal community. The underlying hypothesis is that the VMT will lead to less inflammation and higher prevalence of vaginal Lactobacillus compared to antibiotics alone. The transplant material will be vaginal fluid collected from healthy donors (also known as Donors) using a disposable menstrual cup.

Donors are defined as participants with Nugent scores <4. Over a 16-week period, donors will provide vaginal fluid via softcups (referred to as "donations"). All donations will undergo extensive testing for sexually transmitted infections (STIs) and other infections. Donations that test negative for specified infections will be processed to generate vaginal microbial transplantation (VMT) doses for recipients.

Recipients are defined as participants with Nugent scores ≥4. Because the HPV vaccine is not routinely administered in South Africa, all recipients without documented proof of prior HPV vaccination will receive the HPV vaccine at least 30 days prior to the intervention. The intervention includes the standard of care for bacterial vaginosis in both the U.S. and South Africa: oral metronidazole (MTZ), administered twice daily for seven days. Following completion of the MTZ course, recipients will receive three VMT doses administered over approximately 1.5 weeks. Recipients will be randomized in a 2:1 ratio to receive either VMT or placebo and will be followed for six months post-intervention.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

75

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sarah M Eisa, MPH
  • Número de teléfono: 551-689-4016
  • Correo electrónico: seisa@mgh.harvard.edu

Copia de seguridad de contactos de estudio

  • Nombre: Eyerusalem T Alemu, BA
  • Número de teléfono: 619-522-4661
  • Correo electrónico: ealemu@mgh.harvard.edu

Ubicaciones de estudio

  • Sudáfrica
      • Durban, Sudáfrica
        • FRESH Clinic
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Rosie Mngqbisa, MBChB, MPH
        • Sub-Investigador:
          • Funidiswe Chonco, MD
        • Sub-Investigador:
          • Siphesihle R Ngcobo, MD
        • Investigador principal:
          • Thumbi Ndung'u, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Premenopausal females between 18 to 25 years of age who are enrolled in the FRESH study
  • Nugent score ≥ 4
  • Confirmation of use of effective contraceptive method by all study recipient participants (referred to as recipients) of child-bearing potential, which includes use of at least one of the following: Hormonal method, such as birth control pills, patches, injections, vaginal rings, or implants; Barrier method, such as a condom or diaphragm used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD) - non-levonorgestrel containing
  • Ability and willingness to give written informed consent.

Exclusion Criteria:

  • History of clinically significant vaginal, cervical, or uterine disease including but not limited to cancer of the female reproductive tract, prior hysterectomy, high grade cervical dysplasia (CIN III), or diagnosed with cervicovaginal infection (with the exception of bacterial vaginosis or yeast) within the 30 days prior to the procedure
  • Allergy to metronidazole
  • Use of investigational therapies or investigational vaccines within 90 days prior to study screening
  • Has not received the HPV vaccine and is not willing to be vaccinated
  • Metabolic syndrome, e.g. diabetes, pre-diabetes, glucose intolerance
  • Use of any immunomodulatory agents within 30 days prior to study enrollment
  • Participants taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons, or systemic chemotherapy
  • History of coronary artery disease, myocardial infarction, COPD, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study
  • Pap smear result of LSIL, HSIL, AGUS
  • Insertion of levonorgestrel-containing IUD within 90 days prior to study enrollment
  • Either breastfeeding, pregnant, or trying to conceive within 24 weeks prior to study enrollment; or becomes pregnant during study period

  • Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study

    - NOTE: Oral yogurt with live cultures and fermented foods are allowed.

  • Routine use of oral antibiotics i.e., daily use for acne, Hiradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days
  • Taken non-metronidazole antibiotics in last 30 days
  • Taken metronidazole within the last 2 weeks
  • BMI > 40

  • Positive for any of the STIs listed below or on treatment for any of them.

    • Neisseria gonorrhoeae
    • Chlamydia trachomatis
    • HIV
    • Trichomonas vaginalis
    • Syphilis
    • Mycoplasma genitalium
  • Currently employed at, or professionally affiliated with the FRESH clinical research site, UKZN's HIV Pathogenesis Program (HPP), or the Ragon Institute of Mass General Brigham, MIT and Harvard (referred to as "the Ragon/MGH" in this document).
  • Screens positive for TB by symptomatic questionnaire

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Recipient: Placebo
Women in this group will be randomized to receive three doses of sterile saline solution after completing a full course of MTZ
Droga: oral metronidazole
Metronidazole 400 mg PO every 12 hours for 7 days is the concomitant medication. This antibiotic course is the standard Bacterial Vaginosis (BV) treatment which effectively eliminates microbes associated with BV for a limited time.
Otro: Sterile saline solution
1mL of sterile saline solution
Comparador activo: Recipient: Vaginal Microbiome Transplantation (VMT)
Women in this group will be randomized to receive three doses of VMT after completing a full course of MTZ
Droga: oral metronidazole
Metronidazole 400 mg PO every 12 hours for 7 days is the concomitant medication. This antibiotic course is the standard Bacterial Vaginosis (BV) treatment which effectively eliminates microbes associated with BV for a limited time.
Biológico: Vaginal Microbiome Transplantation (VMT)
Vaginal fluid from healthy donors

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate the safety of VMT
Periodo de tiempo: for 23 weeks after intervention
The primary outcome of the study is to evaluate if VMT increases the proportion of women with a Lactobacillus crispatus-dominant microbiota at any time within the 4 weeks after the first dose as measured by sequencing of the microbial community where Lactobacillus crispatus make up > 50% of detected microbes.
for 23 weeks after intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Determine whether VMT will result in a durable change in vaginal microbiota
Periodo de tiempo: 2, 12, and 24 weeks after intervention
Secondary outcome will measure Lactobacillus crispatus dominance across follow-up weeks. The hypothesis is that antibiotic plus VMT therapy will increase the proportion of women with a Lactobacillus crispatus-dominant microbiota from 5-10% to 50-60%. The safety, toxicity, and tolerability of VMT will also be assessed via a) follow up pelvic assessments to assess for rash, irritation or infection calls, b) patient symptom questionnaires to assess self-reported symptoms of vulvovaginal discomfort, and c) adverse event reporting.
2, 12, and 24 weeks after intervention
Characterize the host clinical and subclinical mucosal inflammatory response before and after VMT
Periodo de tiempo: 24 weeks after intervention
Additional secondary, exploratory analyses will be done to evaluate mechanisms for increased Lactobacillus prevalence, or lack thereof. This will include measuring proportions of individual Lactobacillus species (e.g., L. crispatus, L. iners, L. jensenii, L. gasseri), assessing vaginal microbial community type, microbial community diversity measures, individual taxa associated with treatment group, and host mucosal inflammatory immune response. (e.g., vaginal concentration of IL1beta, IL1alpha, IL1RA, IL6, IL8, TNFa, IFNg)
24 weeks after intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Douglas Kwon

Colaboradores

Massachusetts General Hospital
Bill and Melinda Gates Foundation

Investigadores

  • Investigador principal: Caroline Mitchell, MD, MPH, Massachusetts General Hospital
  • Investigador principal: Douglas S Kwon, MD, PhD, Ragon Institute of MGB, MIT, and Harvard
  • Investigador principal: Krista Dong, MD, Ragon Institute of MGB, MIT, and Harvard

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026P000260

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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