RECRUITING

Vaginal Microbiota Transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.

Official Title

Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities

Quick Facts

Study Start:2021-04-22

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04046900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Premenopausal women, 18- 50 years old * Abnormal Nugent score: \> 3 * History of recurrent bacterial vaginosis (BV) (3 or more documented episodes in past 12 months) * If participating in sexual activity that could lead to pregnancy, study participants must agree to use an effective contraceptive while actively participating in the protocol. At least one of the following methods MUST be used: * Condoms (male or female), with or without a spermicidal agent * Intrauterine device (IUD) * Hormonal contraceptive (including oral pills, vaginal ring, implant, injection)	* 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) within the 30 days prior to the procedure. * Allergy to metronidazole * Use of investigational therapies or investigational vaccines within 90 days prior to study entry * Use of any immunomodulatory agents within 30 days prior to study enrollment. Subject taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted) 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. * History of abnormal pap smear within 12 months * Insertion of levonorgestrel-containing IUD within 3 months prior to study entry * Either breastfeeding or pregnant within 24 weeks prior to study entry * Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study. (NOTE: Oral yogurt with live cultures is allowed.) * Routine use of oral antibiotics i.e. daily use for acne, Hidradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days. * Taken non-metronidazole antibiotics in last 30 days * BMI \> 40

Inclusion Criteria

Exclusion Criteria

* Premenopausal women, 18- 50 years old
* Abnormal Nugent score: \> 3
* History of recurrent bacterial vaginosis (BV) (3 or more documented episodes in past 12 months)
* If participating in sexual activity that could lead to pregnancy, study participants must agree to use an effective contraceptive while actively participating in the protocol. At least one of the following methods MUST be used:
* Condoms (male or female), with or without a spermicidal agent
* Intrauterine device (IUD)
* Hormonal contraceptive (including oral pills, vaginal ring, implant, injection)

* 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) within the 30 days prior to the procedure.
* Allergy to metronidazole
* Use of investigational therapies or investigational vaccines within 90 days prior to study entry
* Use of any immunomodulatory agents within 30 days prior to study enrollment. Subject taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted) 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.
* History of abnormal pap smear within 12 months
* Insertion of levonorgestrel-containing IUD within 3 months prior to study entry
* Either breastfeeding or pregnant within 24 weeks prior to study entry
* Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study. (NOTE: Oral yogurt with live cultures is allowed.)
* Routine use of oral antibiotics i.e. daily use for acne, Hidradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days.
* Taken non-metronidazole antibiotics in last 30 days
* BMI \> 40

Contacts and Locations

Study Contact

Doug Kwon, MD, PhD

CONTACT

857-268-7009

dkwon@mgh.harvard.edu

Principal Investigator

Doug Kwon, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Douglas Kwon

Doug Kwon, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-22

Study Completion Date2026-04

Study Record Updates

Study Start Date2021-04-22

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Bacterial Vaginosis