Background: Perimenopause is characterised by fluctuating ovarian hormones and a heterogeneous, multisystem symptom profile that can substantially impair quality of life (QoL). Non-hormonal management options remain limited for women who are unable or unwilling to use hormone replacement therapy (HRT). Emerging evidence implicates alterations in the gut microbiome in perimenopause-related symptom burden, suggesting microbiome-targeted interventions may offer a novel approach.
Objective: Explore the impact of daily supplementation with Symprove, a water-based multi-strain live-bacteria supplement, on QoL and symptom burden in women experiencing perimenopause.
Methods: This was a 12-week, single-arm, real-world evidence (RWE) pilot study conducted in the United Kingdom. Women experiencing perimenopausal symptoms were recruited via a menopause-focused digital community and received a daily dose of Symprove (70 mL/day). Outcomes were assessed at baseline and weeks 4, 8, and 12 using validated patient-reported measures. The primary outcome was change in menopause-specific QoL measured by the Menopause-Specific Quality of Life (MENQOL) questionnaire. Secondary outcomes included MENQOL domain scores (vasomotor, psychosocial, physical, sexual), gastrointestinal symptoms (Midlife Women’s Symptom Index gastrointestinal subscale; MSI-GI), overall symptom burden (MSI), and sleep regularity (Sleep Regularity Questionnaire; SRQ). Analyses were conducted in the intention-to-treat (ITT) population.
Results: ITT population comprised n=197 at baseline and n=140 at week 12. Mean MENQOL total score improved from 4.52 (SD 1.11) at baseline to 2.44 (SD 0.94) at week 12 (mean change −2.07; p<0.001). Overall, 98% of participants saw an average of 46% reduction in symptom burden across MENQOL domains, with 84% achieving a clinically meaningful improvement (≥1 point reduction). Gastrointestinal symptom burden decreased by 63% (MSI-GI mean change −4.36; p<0.001), and overall symptom burden decreased by 52% (MSI mean change −37.28; p<0.001). Sleep regularity improved by 15% over the study period (SRQ mean change +3.37; p<0.001). Improvements were consistent in exploratory analyses of participants using and not using HRT. Adherence was high (89.3% ≥75% use), and Symprove was generally well tolerated.
Conclusions: In this 12-week, RWE pilot study, daily supplementation with Symprove was associated with improvements across menopause-specific QoL, gastrointestinal symptoms, overall symptom burden, and sleep regularity in women experiencing perimenopause.
