Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women (RESW101)

28. maj 2026 opdateret af: Able Biolabs, LLC

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of a Postbiotic Supplement (resW) on Menopausal Symptoms and Hormonal Balance in Premenopausal Women

The goal of this consumer health study is to evaluate the effect of resW™ Perimenopause Postbiotic on menopausal symptom severity, menopause-related quality of life, and selected microbiome-related outcomes in generally healthy perimenopausal women aged 35 to 55 years.

Participants will be randomized to receive either the active supplement or placebo daily for 4 weeks. Participants will complete electronic questionnaires at baseline and during the study. A predefined subset of participants will also complete stool and vaginal sample collection at baseline and Week 4.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, double-blind, placebo-controlled, parallel-group consumer health study evaluating the effect of resW™ Perimenopause Postbiotic in generally healthy perimenopausal women aged 35 to 55 years.

Eligible participants will be randomized in a 1:1 ratio to receive either resW™ Perimenopause Postbiotic or placebo for 4 weeks. Participants will take 2 capsules daily and complete electronic study questionnaires through the Chloe app. Menopausal symptom severity and menopause-related quality of life will be assessed using the Greene Climacteric Scale and Cervantes Short Form at baseline and Week 4, with an interim Greene Climacteric Scale assessment at Week 2.

A predefined microbiome substudy subset of approximately 20 participants will complete stool and vaginal sample collection at baseline and Week 4. These samples will be used to evaluate exploratory changes in stool microbiome composition, vaginal microbiome composition, and vaginal pH.

Safety and tolerability will be monitored throughout the study through adverse event reporting, compliance tracking, and participant-reported feedback.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater, 75247
        • Able Biolabs LLC

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Provide voluntary, signed, and dated informed consent.
  • Female, aged 35 to 55 years, inclusive.
  • Currently experiencing perimenopausal symptoms, such as hot flashes, mood changes, sleep disturbance, or irregular cycles.
  • In generally good health as determined by self-reported medical history.
  • Agree to maintain existing diet, exercise, and lifestyle patterns throughout the study period.
  • Able and willing to comply with all study procedures, including electronic consent, app-based data entry, and study questionnaires.
  • Participants selected for the microbiome substudy must be willing to complete stool and vaginal sample collection.
  • Females of childbearing potential must agree to use a medically acceptable form of birth control during the study.
  • Agree to refrain from taking other probiotic, prebiotic, postbiotic, hormonal, or menopause-support supplements during the study.
  • Have reliable internet or smartphone access.

Exclusion Criteria:

  • Currently pregnant, planning to become pregnant, or breastfeeding.
  • History or current diagnosis of gynecologic disorders or other conditions affecting hormonal balance.
  • Current or recent use of hormone replacement therapy or hormonal medications.
  • History of unstable or newly diagnosed cardiovascular, hepatic, renal, or significant metabolic disorders.
  • Known gastrointestinal disease or condition affecting absorption or metabolism.
  • Known allergy or sensitivity to any ingredient in the study supplement.
  • Current participation in another clinical study involving an investigational product or device, or participation in such a study within the past 30 days.
  • Any other medical or psychiatric condition that, in the opinion of the investigator or study team, could interfere with study participation, compliance, or interpretation of study results.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Andet: Placebo
Inactive supplement
Eksperimentel: Supplement
Kosttilskud: Supplement
Active supplement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Greene Climacteric Scale total score from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in the Greene Climacteric Scale total score. The Greene Climacteric Scale is a 21-item questionnaire assessing climacteric symptoms. Total scores range from 0 to 63, with higher scores indicating greater climacteric symptom severity, which is a worse outcome.
Baseline to Week 4
Changes in gut microbiota composition associated with hormonal health
Tidsramme: 4 weeks
Change from baseline to Week 4 in gut microbiota composition assessed using stool sample microbiome sequencing. Gut microbiota composition will be evaluated by measures including microbial taxonomic relative abundance and diversity metrics derived from sequencing data. This outcome will assess changes in the composition of bacterial taxa in stool samples associated with hormonal health.
4 weeks
Change in Cervantes Short Form total score from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in the Cervantes Short Form Scale total score. The Cervantes Short Form Scale is a validated menopause-specific quality-of-life questionnaire assessing menopause-related quality of life across physical, psychological, and aging-related domains. Total scores range from 0 to 100, with higher scores indicating poorer menopause-related quality of life, which is a worse outcome.
Baseline to Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in stool microbiome alpha diversity from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in stool microbiome alpha diversity, assessed using diversity indices such as the Shannon diversity index, Simpson diversity index, or observed amplicon sequence variants/species richness, in participants enrolled in the microbiome substudy.
Baseline to Week 4
Change in stool microbial taxonomic composition from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in the relative abundance of stool microbial taxa, assessed using stool sample microbiome sequencing, in participants enrolled in the microbiome substudy.
Baseline to Week 4
Change in vaginal microbiome alpha diversity from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in vaginal microbiome alpha diversity, assessed using diversity indices such as the Shannon diversity index, Simpson diversity index, or observed amplicon sequence variants/species richness, in participants enrolled in the microbiome substudy.
Baseline to Week 4
Change in relative abundance of vaginal microbial taxa from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in the relative abundance of vaginal microbial taxa, including Lactobacillus species and bacterial vaginosis-associated taxa, assessed using vaginal sample microbiome sequencing, in participants enrolled in the microbiome substudy.
Baseline to Week 4
Change in vaginal pH from baseline to Week 4
Tidsramme: Baseline to Week 4
Change from baseline to Week 4 in vaginal pH, measured from vaginal samples using a pH test method, in participants enrolled in the microbiome substudy. Vaginal pH is measured on a continuous scale, with higher values indicating greater vaginal alkalinity.
Baseline to Week 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Able Biolabs, LLC

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)

4. marts 2026

Primær færdiggørelse (Faktiske)

15. maj 2026

Studieafslutning (Faktiske)

27. maj 2026

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABL-032503

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Menopausale symptomer

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner