Menopause Other
Conditions
Interventions
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.
Sponsors
Symprove Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life measured using the Menopause-Specific Quality of Life (MENQOL) questionnaire at baseline, and weeks 4, 8 and 12 (follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, United Kingdom
Contacts
Public ContactSammie Gill
Outcome results
None listed