Impact of a probiotic supplement on menopause

  • Research type

    Research Study

  • Full title

    A single-arm, virtual, real-world evidence pilot study to assess the impact of a probiotic supplement in women with perimenopause symptoms

  • IRAS ID

    352166

  • Contact name

    Nigel Denby

  • Contact email

    nigel@harleystathome.com

  • Sponsor organisation

    Symprove Ltd

  • Duration of Study in the UK

    0 years, 6 months, 31 days

  • Research summary

    Menopause can have a significant impact on the quality of life. Many women struggle with mental and physical menopause symptoms, including problems with sleeping, forgetfulness and mood swings. Hormone replacement therapy is an effective solution for helping with menopause symptoms, but a balanced diet and exercise can also help. There is some evidence suggesting that menopause may reduce the diversity of the gut microbiome, which are the microorganisms living in the gut. However, more research is needed to understand the possible benefits of gut health supplements such as probiotics during menopause.

    The aim of our pilot study is to assess the impact of a gut supplement called Symprove on early menopause symptoms. Symprove is a water-based solution that contains billions of live and active bacteria, which can help stimulate the good bacteria already in the gut. We will recruit a minimum of 100 perimenopausal women who are experiencing symptoms related to perimenopause. All participants will be recruited through Harley Street at Home (https://www.harleystathome.com).

    This is a non-randomised virtual study, which does not involve any study visits. After providing consent to take part using an online consent form, all participants will receive a 12-week course of Symprove to take once a day. Participants will also receive a link to complete an online study survey about their perimenopause and gut symptoms at the beginning of the study before starting Symprove (Baseline), and at weeks 4, 8 and 12 (follow-up). To assess the impact of Symprove on menopause symptoms, we will compare the follow-up data to Baseline.

    The study is sponsored and organized by Symprove Ltd.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    25/NW/0123

  • Date of REC Opinion

    30 May 2025

  • REC opinion

    Further Information Favourable Opinion