Impact of a probiotic supplement on menopause
| ISRCTN | ISRCTN56831337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56831337 |
| IRAS number | 352166 |
- Submission date
- 08/08/2025
- Registration date
- 12/08/2025
- Last edited
- 12/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
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 is 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. This pilot study aims 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.
Who can participate?
Perimenopausal women who are experiencing symptoms related to perimenopause.
What does the study involve?
All participants will be recruited through Harley Street at Home (https://www.harleystathome.com). This is a virtual study that does not involve any study visits or allocation to groups. 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 the Baseline.
What are the possible benefits and risks of participating?
Although participants may not receive any health benefit from taking part, research like this can improve our understanding of menopause and help develop new ways to manage it in the future.
A small number of people may experience mild gut disturbances (such as bloating or a change in bowel habit) when they first start taking Symprove. Disturbances will usually resolve in the first few weeks.
Where is the study run from?
Symprove Ltd, UK
When is the study starting and how long is it expected to run for?
December 2024 to December 2025
Who is funding the study?
Symprove Ltd, UK
Who is the main contact?
Mr Nigel Denby, nigel@harleystathome.com
Contact information
Public, Scientific
Symprove Ltd
Sands Rd, The Sands
Farnham
GU10 1PX
United Kingdom
| Phone | +44(0)1252413600 |
|---|---|
| sammie@symprove.com |
Principal Investigator
Unit 8a Wingbury Courtyard Business Village
Aylesbury
HP22 4LW
United Kingdom
 ORCID ID |
0009-0001-4892-294X |
|---|---|
| Phone | +44 (0)7941396610 |
| nigel@harleystathome.com |
Study information
| Study design | Single-arm virtual real-world evidence pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Internet/virtual |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Scientific title | A single-arm, virtual, real-world evidence pilot study to assess the impact of Symprove in women with perimenopause symptoms |
| Study objectives | To explore the effects of Symprove (70 ml per day) in perimenopausal women |
| Ethics approval(s) |
Approved 30/05/2025, North West - Preston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048364; preston.rec@hra.nhs.uk), ref: 25/NW/0123 |
| Health condition(s) or problem(s) studied | Menopause |
| Intervention | All participants will receive a 12-week course of Symprove to take 70ml once a day. Symprove is a gut supplement that contains billions of live and active bacteria. |
| Intervention type | Supplement |
| Primary outcome measure | Quality of life measured using the Menopause-Specific Quality of Life (MENQOL) questionnaire at baseline, and weeks 4, 8 and 12 (follow-up) |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline, and weeks 4, 8 and 12 (follow-up): 1. Quality of life measured using the Menopause-Specific Quality of Life (MENQOL) questionnaire 2. Gastrointestinal symptoms measured using the Gastrointestinal Symptom Index for Midlife Women (MSI-GI) 3. Other perimenopausal symptoms measured using the Midlife Women's Symptom Index (MSI) 4. Sleep disturbances measured using the Sleep Regularity Questionnaire (SRQ) |
| Overall study start date | 01/12/2024 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Service user, Other |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Had a period in the last 12 months 2. Experienced menstrual cycles of variable length, skipped cycles and/or had no period for 60 days or more 3. Experiencing regular (e.g. daily or weekly) symptoms related to perimenopause (e.g. night sweats, hot flushes, gut symptoms, mood changes, trouble with concentration/memory, sleep disturbances, headaches) NB: this is not an exhaustive list 4. Symptoms are affecting quality of life |
| Key exclusion criteria | 1. Currently taking probiotics or prebiotics supplements (e.g. Bimuno) or yogurts containing probiotics (e.g. Yakult, Actimel) 2. Took Symprove in the last 6 months 3. Started taking hormone replacement therapy (HRT) within the last 3 months 4. Diagnosed with gut conditions other than Irritable Bowel Syndrome, such as inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis), coeliac disease, hepatitis, gallstones, acid reflux/dyspepsia. NOTE: Irritable Bowel Syndrome is not an exclusion criterion 5. Diagnosed with any significant psychological issues (such as depression, bipolar illness, psychosis) 6. Diagnosed with any significant heart, lung or kidney issues 7. Receiving treatment for cancer 8. Currently pregnant or breastfeeding |
| Date of first enrolment | 11/08/2025 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wingrave
Aylesbury
HP22 4LW
United Kingdom
Sponsor information
Industry
Sands Rd, The Sands
Farnham
GU10 1PX
England
United Kingdom
| Website | https://www.symprove.com/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal and Harley Street at Home's website. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (Symprove Ltd). |
Editorial Notes
12/08/2025: Plain English summary of protocol updated with benefits and risks.
08/08/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
