A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women (RESW101)
28 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Texas
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Dallas, Texas, Estados Unidos, 75247
- Able Biolabs LLC
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
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Inactive supplement
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Experimental: Suplemento
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Active supplement
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Greene Climacteric Scale total score from baseline to Week 4
Periodo de tiempo: 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.
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Baseline to Week 4
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Changes in gut microbiota composition associated with hormonal health
Periodo de tiempo: 4 weeks
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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.
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4 weeks
|
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Change in Cervantes Short Form total score from baseline to Week 4
Periodo de tiempo: 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.
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Baseline to Week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in stool microbiome alpha diversity from baseline to Week 4
Periodo de tiempo: Baseline to Week 4
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline to Week 4
|
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Change in relative abundance of vaginal microbial taxa from baseline to Week 4
Periodo de tiempo: 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
Periodo de tiempo: Baseline to Week 4
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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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de marzo de 2026
Finalización primaria (Actual)
15 de mayo de 2026
Finalización del estudio (Actual)
27 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ABL-032503
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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