A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women (RESW101)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Texas
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Dallas, Texas, Spojené státy, 75247
- Able Biolabs LLC
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo
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Inactive supplement
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Experimentální: Doplněk
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Active supplement
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Greene Climacteric Scale total score from baseline to Week 4
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in stool microbiome alpha diversity from baseline to Week 4
Časové okno: 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.
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Baseline to Week 4
|
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Change in stool microbial taxonomic composition from baseline to Week 4
Časové okno: 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.
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Baseline to Week 4
|
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Change in vaginal microbiome alpha diversity from baseline to Week 4
Časové okno: 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
Časové okno: 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.
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Baseline to Week 4
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Change in vaginal pH from baseline to Week 4
Časové okno: 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.
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Baseline to Week 4
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ABL-032503
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