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Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy

14 sierpnia 2018 zaktualizowane przez: John A. Occhino, Mayo Clinic

Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection

The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. The investigators are doing this research study to understand the relationship between microbes (the microbiome) and the occurrence of urinary tract infection following surgical removal of the uterus and pelvic organ prolapse repair. The investigators expect Lactobacillus and Gardnerella will be the dominant organisms for most women. Non-Lactobacillus dominant microbiome communities will be more common in women who ultimately develop postoperative urinary tract infection.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

The goal of this pilot study is to characterize the presence and stability of the microbial community in the vagina and lower urinary tract in a cohort of 20 postmenopausal women undergoing transvaginal hysterectomy with pelvic reconstruction for pelvic organ prolapse. The investigators intend to collect longitudinal samples in the preoperative, intraoperative, and postoperative time period in order to understand the pervasiveness of the microbes in the vagina and lower urinary tract, and to identify, in a very preliminary way, particular microbes that may be associated with postoperative urinary tract infection.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

25

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Mayo Clinic in Rochester

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Postmenopausal women undergoing pelvic reconstructive surgery for pelvic organ prolapse.

Opis

Inclusion Criteria:

  • Postmenopausal females (defined by cessation of menses for one full year)
  • Planned surgical correction of pelvic organ prolapse with transvaginal hysterectomy and concomitant pelvic reconstruction for uterovaginal prolapse
  • Scheduled surgery date within 4 weeks of study consent
  • Physically able to self-collect vaginal swabs and clean-catch urine samples

Exclusion Criteria:

  • Women who are premenopausal, pregnant or nursing
  • Currently taking or have taken antibiotics in the past 2 weeks
  • History of recurrent urinary tract infections
  • History of mesh complications, including erosion/extrusion
  • Non-vaginal approach to hysterectomy or prolapse repair

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: 1 day (Pre-operative Urogynecology surgical consultation visit)
Vaginal swabs will be collected from participants at the surgical consultation visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
1 day (Pre-operative Urogynecology surgical consultation visit)
Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: 1 day (Pre-operative Urogynecology surgical consultation visit)
Urine sample will be collected from participants at the surgical consultation visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
1 day (Pre-operative Urogynecology surgical consultation visit)
Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Vaginal swabs will be collected from participants on the day of surgery, prior to entering the surgical suite. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Urine sample will be collected from participants on the day of surgery, prior to entering the surgical suite. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: Within 6 hours of collecting the pre-operative sample
Vaginal swabs will be collected from participants at the end of the surgical procedure. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
Within 6 hours of collecting the pre-operative sample
Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: Within 6 hours of collecting the pre-operative sample
Urine sample will be collected from participants at the end of the surgical procedure. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Within 6 hours of collecting the pre-operative sample
Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: 12-18 hours after surgery
Vaginal swabs will be collected from participants the morning following surgery, after removal of the vaginal packing. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
12-18 hours after surgery
Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: 12-18 hours after surgery
Urine sample will be collected from participants the morning following surgery, after removal of the vaginal packing. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
12-18 hours after surgery
Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: Within the first 6 weeks after surgery
Vaginal swabs will be collected at the onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition in the vagina in the setting of urinary tract infection and compare to microbiome of vagina during the perioperative period.
Within the first 6 weeks after surgery
Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: Within the first 6 weeks after surgery
Urine sample will be collected at the onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract in the setting of urinary tract infection and compare to microbiome of the urinary tract during the perioperative period.
Within the first 6 weeks after surgery
Identification of key biomarkers associated with risk of postoperative urinary tract infection through proteomic mass spectrometry analysis of vaginal swab collected in the setting of postoperative urinary tract infection
Ramy czasowe: Within the first 6 weeks after surgery
Vaginal swab collected at onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit. Proteomic mass spectrometry analysis of vaginal swab will be conducted. The investigators will use this proteomic information together with the microbial community identified with 16S rRNA to identify a transition point or key biomarkers associated with risk of postoperative urinary tract infection.
Within the first 6 weeks after surgery
Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: 6 weeks (up to 8 weeks)
Vaginal swabs will be collected from participants at the Urogynecology post-surgical consultation. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
6 weeks (up to 8 weeks)
Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
Ramy czasowe: 6 weeks (up to 8 weeks)
Urine sample will be collected from participants at the Urogynecology post-surgical consultation. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
6 weeks (up to 8 weeks)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Mayo Clinic

Śledczy

  • Główny śledczy: John A Occhino, M.D., Mayo Clinic

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2016

Zakończenie podstawowe (Rzeczywisty)

31 maja 2017

Ukończenie studiów (Rzeczywisty)

30 lipca 2018

Daty rejestracji na studia

Pierwszy przesłany

22 lutego 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 kwietnia 2016

Pierwszy wysłany (Oszacować)

26 kwietnia 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 sierpnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 sierpnia 2018

Ostatnia weryfikacja

1 sierpnia 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 15-006300

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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