MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH (MOTIF@FRESH)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Sarah M Eisa, MPH
- 전화번호: 551-689-4016
- 이메일: seisa@mgh.harvard.edu
연구 연락처 백업
- 이름: Eyerusalem T Alemu, BA
- 전화번호: 619-522-4661
- 이메일: ealemu@mgh.harvard.edu
연구 장소
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Durban, 남아프리카
- FRESH Clinic
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연락하다:
- Thembelihle Dlamini
- 전화번호: +27 73 318 9320
- 이메일: lihle.fresh@ragoninsa.org
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연락하다:
- Sooseela V Pillay
- 전화번호: +27 31- 9060394
- 이메일: vanessa.fresh@ragoninsa.org
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수석 연구원:
- Rosie Mngqbisa, MBChB, MPH
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부수사관:
- Funidiswe Chonco, MD
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부수사관:
- Siphesihle R Ngcobo, MD
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수석 연구원:
- Thumbi Ndung'u, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Recipient: Placebo
Women in this group will be randomized to receive three doses of sterile saline solution after completing a full course of MTZ
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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.
1mL of sterile saline solution
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활성 비교기: 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
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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.
Vaginal fluid from healthy donors
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluate the safety of VMT
기간: for 23 weeks after intervention
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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.
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for 23 weeks after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Determine whether VMT will result in a durable change in vaginal microbiota
기간: 2, 12, and 24 weeks after intervention
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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.
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2, 12, and 24 weeks after intervention
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Characterize the host clinical and subclinical mucosal inflammatory response before and after VMT
기간: 24 weeks after intervention
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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)
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24 weeks after intervention
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Caroline Mitchell, MD, MPH, Massachusetts General Hospital
- 수석 연구원: Douglas S Kwon, MD, PhD, Ragon Institute of MGB, MIT, and Harvard
- 수석 연구원: Krista Dong, MD, Ragon Institute of MGB, MIT, and Harvard
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026P000260
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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