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Postbiotic Supplement for Premenopause

(RESW101 Trial)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a postbiotic supplement to determine its effectiveness in improving menopausal symptoms in women before menopause. Researchers aim to find out if taking the supplement daily for eight weeks results in a noticeable difference compared to a placebo (a pill with no active ingredients). Women who are generally healthy, aged 35 to 55, and not currently on hormone replacement therapy may be suitable candidates for this study. Participants will complete questionnaires to report their symptoms throughout the trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new solutions for menopausal symptoms.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must avoid other probiotic, prebiotic, hormonal, or menopause-support supplements during the study.

Is there any evidence suggesting that this postbiotic supplement is likely to be safe for humans?

Research has shown that postbiotic supplements are generally safe for healthy individuals. Studies have found that probiotics, which are similar to postbiotics, can be safely used by those without immune system issues. For instance, a review of several studies found that probiotics had positive effects on menopausal symptoms and were safe to use. Another study noted that a specific postbiotic, L. gasseri CP2305, may help improve women's physical and emotional well-being, indicating it is well-tolerated.

Although this trial does not include a specific safety phase, existing research suggests that postbiotic supplements are likely safe for healthy premenopausal women.12345

Why are researchers excited about this trial?

Most treatments for premenopause focus on hormone replacement therapy or lifestyle changes to manage symptoms. However, this postbiotic supplement is unique because it introduces beneficial compounds produced by gut bacteria, which may help balance hormones naturally. Researchers are excited about its potential to enhance gut health and, in turn, improve overall hormonal balance without the need for synthetic hormones or drastic lifestyle changes. This approach could offer a more natural and gentle alternative to managing premenopausal symptoms.

What evidence suggests that this postbiotic supplement might be an effective treatment for menopausal symptoms?

Research has shown that postbiotic supplements might help with menopausal symptoms. For example, one study found that a specific postbiotic, L. gasseri CP2305, improved sleep, reduced stress, and boosted emotional well-being in menopausal women. Another study discovered that probiotics enhanced overall quality of life during menopause, including reducing anxiety and depression. Additionally, a review of several studies suggests that probiotics positively impact menopausal symptoms, such as urogenital and bone health. This trial will evaluate the effectiveness of a postbiotic supplement for managing symptoms in premenopausal women, with participants receiving either the supplement or a placebo.12345

Are You a Good Fit for This Trial?

Inclusion Criteria

My blood pressure, heart rate, and physical exam results are normal or acceptable.
* Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
* Provide voluntary signed and dated informed consent
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take the supplement/placebo daily for 8 weeks and complete questionnaires on a regular basis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Postbiotic Supplement

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SupplementExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Able Biolabs, LLC

Lead Sponsor

Citations

Probiotics and Prebiotics: Any Role in Menopause-Related ...

Of note, probiotic supplementation was effective also on the improvement of genitourinary symptoms in women treated for BC as consequences of chemotherapy and ...

Meta-analysis Investigating the effects of probiotics during ...

The results demonstrated that probiotics had positive effects on menopausal symptoms, urogenital health, bone health, and the efficacy and safety of estriol ...

Postbiotic Supplement for Premenopause (RESW101 Trial)

The goal of this consumer study is to evaluate the efficacy of a postbiotic supplement on menopausal symptoms and hormonal balance in ...

NCT04001088 | The Effects of a Novel Probiotic ...

This Phase II study is designed to evaluate the potential effects of a novel probiotic supplement on the severity of global menopause symptoms (e.g., ...

Spotlight on postbiotics and nutrients to manage sleep, ...

L. gasseri CP2305 postbiotic may improve sleep quality, reduce stress, and boost emotional well-being in menopausal women.“Results from a 2022 ...