Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health
6. april 2021 opdateret af: UAS Labs LLC
An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health
The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health.
Eligible subjects will utilize the investigational product as directed for a period of 28 days.
The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation.
A follow-up post-supplementation visit will be conducted on Day 42.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
37
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 0B4
- Nutrasource
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Healthy women aged 18-50 years.
- Body mass index 18.5 - 34.9 kg/m2 (inclusive).
- Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater than one year since last menses)].
- Non-smoker, or ex-smoker ≥6 months.
- Nugent score of 4-6 or pH >4.5
- Agrees to maintain current level of physical activity and dietary habits throughout the trial period.
- Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food supplemented with probiotics or prebiotics.
- Willing and able to provide written informed consent.
- Agrees to provide fecal samples during the trial period.
Exclusion Criteria:
- Hypersensitivity to any ingredient in the study product.
- Pregnancy or planning pregnancy.
- Lactation or breast feeding.
- Irregular menstrual cycles.
- Use of contraceptives that contain spermicidal agents.
- Use of an intrauterine device (IUD).
- Use of hormonal therapy through cervical cap.
- Use of douching devices.
- Any major trauma or surgical event within the 3 months prior to screening.
- Individuals undergoing therapies to prevent any recurrent infections.
- Allergy to any antibiotic that may be prescribed as a rescue remedy during the study.
- Use of prescription drugs (other than birth control) within 1 month prior to Visit 1.
- Use of antibiotics within 2 months prior to Visit 1.
- History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
- Presence of systemic diseases or immunodeficiencies
- Abdominal or gastrointestinal surgery within the previous 12 months.
- Recent gastrointestinal food-borne illness (within 1 month prior to Visit 1)
- History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
- Abnormal laboratory test results of clinical significance
- Presence or history (past 6 months) of alcohol or drug abuse
- Subject is unwilling or unable to abide by the requirements of the protocol
- Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
- Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Oral probiotic product
|
Once per day (QD), 28 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in vaginal microbial community, via next generation sequencing.
Tidsramme: Day 28
|
Day 28
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in vaginal microbial community, via next generation sequencing.
Tidsramme: Day 14 and 42
|
Day 14 and 42
|
|
Changes in vaginal pH.
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
|
Changes in Nugent Score (Scale of 0 to 10).
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
|
Parameters of well-being, via Vulvovaginal Symptom Questionnaire.
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
|
Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
|
Compliance as assessed by capsule counts of the returned IP.
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Colonization of the vaginal microbiome.
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
|
Colonization of the GI microbiome.
Tidsramme: Day 14, 28 and 42
|
Day 14, 28 and 42
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. maj 2018
Primær færdiggørelse (Faktiske)
1. oktober 2020
Studieafslutning (Faktiske)
18. marts 2021
Datoer for studieregistrering
Først indsendt
27. april 2018
Først indsendt, der opfyldte QC-kriterier
20. maj 2018
Først opslået (Faktiske)
1. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UAS1RPD-160001-PRVH
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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