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Probiotic

Probiotic Supplement for Menopause Symptoms

N/A

Waitlist Available

Research Sponsored by Maneuver Marketing

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women aged 45-65 years old

Must experience hot flashes and/or night sweats at least once per day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study Summary

This trial tests if a probiotic supplement can reduce menopause symptoms like hot flashes, night sweats, mood swings, etc. Participants take a test product or placebo daily and provide data on weight, waist, sleep, and symptoms.

Who is the study for?

Women aged 45-65 with menopause, experiencing daily hot flashes/night sweats and at least two other symptoms like sleep issues or mood swings. Participants must not have had a period for the last year, be in good general health, willing to follow the study rules, and stop other supplements. Excluded are those on hormone therapies or with certain medical conditions.Check my eligibility

What is being tested?

This trial tests if Provitalize Natural Menopause Probiotic helps reduce menopause symptoms over 90 days compared to a placebo. Women will report their experiences and provide measurements related to weight loss, waist size, sleep quality, and various menopausal discomforts at multiple points during the study.See study design

What are the potential side effects?

Possible side effects may include allergic reactions to probiotic ingredients for those sensitive to them. However, since this is a natural supplement being tested against a placebo, significant side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 45 and 65.

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I experience hot flashes or night sweats daily.

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I have never taken Provitalize.

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I have no surgeries or invasive procedures planned for the study duration or three weeks before it starts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in body weight. [Timeframe: Baseline to Day 90]

Change in waist circumference. [Timeframe: Baseline to Day 90]

Changes in scores on the Bristol Stool Chart. [Timeframe: Baseline to Day 90]

Secondary outcome measures

Changes in overall sleep score provided by Fitbit wearable sleep tracker. [Timeframe: Baseline to Day 90]

Changes in the frequency of bloating. [Timeframe: Baseline to Day 90]

Changes in the frequency of hot flashes. [Timeframe: Baseline to Day 90]

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Provitalize ProbioticExperimental Treatment1 Intervention

Participants will take 2 capsules every morning on an empty stomach before their first meal of the day.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take 2 capsules every morning on an empty stomach before their first meal of the day.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Maneuver MarketingLead Sponsor

CitruslabsIndustry Sponsor

68 Previous Clinical Trials

3,745 Total Patients Enrolled

2 Trials studying Menopause

82 Patients Enrolled for Menopause

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial allow seniors to participate?

"As listed on the eligibility criteria, this trial is open to participants between 45 and 65 years old. Alternatively, there are two alternative studies for individuals under 18 or over 65 respectively."

Answered by AI

What are the aims of this investigation?

"This 90-day clinical trial is designed to assess changes in the Bristol Stool Chart. Secondary objectives include analysis of sleep metrics as measured by a Fitbit device, and alterations in the frequency of hot flashes using a 5-point Likert scale (where 0 implies no noticeability and 4 represents severe cases)."

Answered by AI

Are there vacancies remaining in this clinical research?

"According to the publicly available clinicaltrials.gov website, this medical trial is not currently recruiting participants; however, it was first posted on December 1st 2023 and last updated on November 19th 2023. Although this study is no longer actively seeking patients, there are 40 other studies that still require enrolment at present."

Answered by AI

To whom is this research project available?

"This research is seeking 100 participants who are 45 to 65 years old and have gone through menopause. Qualified candidates will be eligible for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause

2023. "A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06148714.

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