RecruitingNAINTERVENTIONAL

Menopausal Symptoms Probiotic Study

This study is exploring if a special mix of good bacteria, called a probiotic blend, can help women manage menopause symptoms. We know that menopause symptoms, like hot flashes and night sweats, are often linked to changes in the body's oestrogen levels. The research aims to see if this particular probiotic can help the body re-use its natural oestrogens more effectively, potentially easing these symptoms. Participants will either receive this probiotic blend or a dummy pill (placebo) to fairly compare the effects. We hope to find a natural way to support women during this significant life change, improving their comfort and quality of life without making medical recommendations.

At a glance

Status

Recruiting

Phase

Sponsor

Community Pharmacology Services Ltd

Enrolment target

140

Start

10 Sep 2024

Estimated completion

25 Oct 2026

Menopause

What is this study about?

Many women experience uncomfortable symptoms during menopause, such as hot flashes and night sweats. These symptoms are closely linked to changes in the body's hormone levels, especially oestrogen. Our bodies naturally produce oestrogen, and this study tries to understand if a special blend of probiotics (good bacteria) can help the body use its own oestrogen more effectively. We believe that by improving the way oestrogen circulates in the body, we might be able to reduce these common menopause symptoms.

In this study, some women will receive the active probiotic product, while others will receive a placebo, which looks identical but contains no active ingredients. This allows us to fairly compare the effects and see if the probiotic blend truly makes a difference. The goal is to see if this particular probiotic can help ease symptoms like hot flashes and night sweats that many women experience during this phase of life. It’s an exploration into supporting women’s health during menopause in a new way.

This research is important because it could offer a gentle, natural approach to managing menopause symptoms. If effective, it could provide women with another option to consider alongside existing treatments, potentially improving their comfort and overall well-being during a significant transition in their lives.

Key takeaways

This study explores if a probiotic blend can help with menopause symptoms.
It aims to see if the probiotic can boost natural oestrogen use.
Participants will receive either the probiotic or a dummy pill (placebo).
Focus is on reducing common symptoms like hot flashes and night sweats.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, we're looking for women between 42 and 60 years old who are going through menopause or have recently finished it. This means you haven't had a period for less than two years and you're experiencing noticeable menopausal symptoms, such as at least five hot flashes or night sweats each day, or 35 or more per week. Your body mass index (BMI) should also be between 18.5 and 34.9, and a doctor will check your menopause symptom score to make sure it's high enough.

There are also some reasons why you might not be able to join. For example, if you've had certain surgeries like a hysterectomy or oophorectomy, or if you've had specific types of cancer. We also can't include you if you've recently used hormone replacement therapy, birth control pills, or other similar hormone treatments within the last three months. If you've recently taken certain herbal supplements for menopause symptoms or any probiotics (even through foods like yoghurt) within the last month, you wouldn't be able to participate either.

Also, if you've been diagnosed with a new mental health condition recently, have uncontrolled diabetes, or certain long-term gut conditions like Crohn's disease, you wouldn't be suitable for this study. It's important that you're willing to follow the study instructions, use contraception if you're still perimenopausal, and not change your diet or lifestyle a lot during the study period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 42 and 60 years old?
Have you stopped having periods for less than two years?
Do you experience at least 5 hot flashes or night sweats per day, or 35+ per week?
Have you avoided hormone therapy, birth control, or certain herbal remedies in the last 3 months?
Have you avoided other probiotics (supplements or frequent probiotic foods) in the last month?
Are you able to follow study instructions and use contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the active probiotic product or a dummy pill (placebo) to take. You won't know which one you're receiving. We'll ask you to keep a daily record of your menopause symptoms, particularly hot flashes and night sweats, for 14 days before the study officially starts to give us a baseline. During the study, you'll continue to track your symptoms regularly. You'll also be asked to attend a series of visits with the study team, where assessments will be carried out to check your health and how you're feeling. The study team will explain everything in detail, including how long you'll need to take the product and any follow-up appointments. The total duration of your participation will be clearly outlined to you before you agree to join.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as a possible reduction in your menopause symptoms if you receive the active probiotic. However, there's no guarantee that you will personally benefit, as some participants will receive a placebo. Every study has potential risks, though we aim to minimise them. These will be fully explained before you agree to participate, including any possible side effects from the probiotic or procedures. Remember, participating in any clinical study is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

FutureMeds Glasgow
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What exactly is a probiotic blend?

A probiotic blend is a mix of different types of 'good' bacteria, similar to those found naturally in your gut. They are thought to have health benefits.

What is oestrogen and why is it important for menopause?

Oestrogen is a hormone that plays many roles in a woman's body. During menopause, levels of oestrogen drop, which can lead to common symptoms like hot flashes and night sweats.

Will I know if I'm getting the probiotic or the dummy pill?

No, you won't know whether you're receiving the active probiotic or the dummy pill (placebo). This helps us get unbiased results.

What are common menopause symptoms this study is looking at?

This study is focusing on common symptoms like hot flashes and night sweats, which can be very disruptive for women.

How long will I be involved in the study?

The full duration of your participation, including all visits and follow-ups, will be clearly explained to you by the study team.

How to find out more

Kristen Laing, MBChB

kristen.laing@futuremeds.com 0141 946 7888 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.