Effect of Multi-Strain Probiotics on Constipation and Quality of Life in Menopausal Women: A Double-Blind, Randomized, Placebo-Controlled, Single-Center Trial
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Abstract
Objective: To evaluate the short-term efficacy of a multi-strain probiotic supplement (Bifidobacterium longum, B. breve, B. lactis, B. animalis TA1, Lactobacillus paracasei MSMC 39-1, L. rhamnosus, L. reuteri TF314, and L. gasseri) in improving bowel movement frequency, stool consistency, and menopause-related quality of life in women with functional constipation.
Materials and methods: A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient clinic of a tertiary care hospital in Bangkok, Thailand, between August 2024 and April 2025. For four weeks, 46 women with functional constipation, as defined by Rome IV, were randomized to receive a probiotic or placebo capsule every day. Simple randomization was carried out by a third party, and the allocation was hidden from the participants and researchers. Pretest–posttest questionnaires were used to measure menopause-specific quality of life (MENQOL) and symptoms associated with constipation. Data were analyzed using the intention-to-treat approach.
Results: In the probiotics group, the median weekly defecation frequency increased significantly (3.0 to 5.0, p=0.003). Hard stools slightly declined from 32% to 9.1% (p=0.200), although not statistically significant (p = 0.200). There were minimal changes in the placebo group. The total MENQOL score, and physical domain improved from 55.1±31.2 to 40.7±22.4 (p=0.012) and from 34.2±21.5 to 24.4±14.1 (p=0.014), respectively, while vasomotor, psychosocial, and sexual domains showed no significant changes. No significant changes occurred in the placebo group. Subgroup analysis of participants over 60 years old showed similar improvements in total score (p=0.041) and physical domain (p=0.029). One participant (4.3%) in the probiotics group discontinued due to bloating.
Conclusions: In menopausal women experiencing constipation, a 4-week multi-strain probiotic treatment demonstrated improvements in the frequency of bowel movements, physical domain and total score of menopause-related quality of life. Probiotics may serve as an adjunctive, non-pharmacological approach to support physical well-being in menopausal women.
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References
Shifren JL, Berek JS. Berek & Novak’s Gynecology. 16th ed. Philadelphia: Lippincott Williams & Wilkins; 2020:432.
Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, et al. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: Study of Women’s Health Across the Nation. Am J Public Health 2006;96(7):1226-35. doi:10.2105/AJPH.2005.066936.
Rao SS. Update on the management of constipation in the elderly: new treatment options. Clin Interv Aging 2010;5:163-71. doi:10.2147/CIA.S9639.
Scott SM, Simrén M, Farmer AD, Dinning PG, Carrington EV, Benninga MA, et al. Chronic constipation in adults: contemporary perspectives and clinical challenges. Neurogastroenterol Motil 2021;33(6):e14050. doi:10.1111/nmo.14050.
Bharucha AE, Pemberton JH, Locke GR. American Gastroenterological Association technical review on constipation. Gastroenterology 2013;144(1):218-38. doi:10.1053/j.gastro.2012.10.028.
Rao SSC. Constipation: evaluation and treatment of colonic and anorectal motility disorders. Gastroenterol Clin North Am 2007;36(3):687-711. doi:10.1016/j.gtc.2007.07.013.
Dimidi E, Zdanaviciene A, Christodoulides S, Taheri S, Louis P, Duncan PI, et al. Randomised clinical trial: Bifidobacterium lactis NCC2818 probiotic vs placebo, and impact on gut transit time, symptoms, and gut microbiology in chronic constipation. Aliment Pharmacol Ther 2019;49(3):251-64. doi:10.1111/apt.15073.
Food and Agriculture Organization of the United Nations; World Health Organization. Probiotics in food: health and nutritional properties and guidelines for evaluation. Rome: FAO; 2006.
Dimidi E, Christodoulides S, Fragkos KC, Scott SM, Whelan K. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr 2014;100(4):1075-84. doi:10.3945/ajcn.114.089151.
Barrea L, Verde L, Auriemma RS, Vetrani C, Cataldi M, Frias-Toral E, et al. Probiotics and prebiotics: any role in menopause-related diseases? Curr Nutr Rep 2023;12(1):83-97. doi:10.1007/s13668-023-00462-3.
Lacy BE, Patel NK. Rome criteria and a diagnostic approach to irritable bowel syndrome. J Clin Med 2017;6(11):99. doi:10.3390/jcm6110099.
Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil 2016;28(3):443-8. doi:10.1111/nmo.12738.
Wiwakplern N, Nualkaew S, Rinthong PO. Comparative study on the effectiveness of triphala maha pikut tablets, triphala maha pikut extract tablets and senna extract tablets in relieving constipation. Hosp Med J 2008;28:89-96.
Radtke JV, Terhorst L, Cohen SM. The menopause-specific quality of life questionnaire: psychometric evaluation among breast cancer survivors. Menopause 2011;18(3):289-95. doi:10.1097/gme.0b013e3181ef975a.
Angkana P, Sathitkarnmanee B. [Effect of hormone replacement therapy on quality of life in menopausal women]. Vajira Med J 2001;45:1-7. Thai.
Ghafar MYA, Yaakup H, Ali RAR, Shah SA. Evaluation of the efficacy of probiotics (MCP® BCMC® strains) treating constipation in elderly patients with multiple chronic co-morbidities: a randomized controlled trial. J Nutr Health Aging 2020;24(10):1066-72. doi:10.1007/s12603-020-1494-1.
Šola KF, Vladimir-Knežević S, Hrabač P, Mucalo I, Saso L, Verbanac D. The effect of multistrain probiotics on functional constipation in the elderly: a randomized controlled trial. Eur J Clin Nutr 2022;76(12):1675-81. doi:10.1038/s41430-022-01189-0.
Ojetti V, Ianiro G, Tortora A, D’Angelo G, Di Rienzo T, Bibbò S, et al. The effect of Lactobacillus reuteri supplementation in adults with chronic functional constipation: a randomized, double-blind, placebo-controlled trial. J Gastrointestin Liver Dis 2014;23(4):387-91. doi:10.15403/jgld.2014.1121.234.elr.
Sawada D, Sugawara T, Hirota T, Nakamura Y. Effects of Lactobacillus gasseri CP2305 on mild menopausal symptoms in middle-aged women. Nutrients 2022;14(9):1764. doi:10.3390/nu14091695.
Uehara S, Monden K, Nomoto K, Seno Y, Kariyama R, Kumon H. A pilot study evaluating the safety and effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection. Int J Antimicrob Agents 2006;28 Suppl 1:S30-4. doi:10.1016/j.ijantimicag.2006.05.008.
Sharma R, Kapila R, Kapasiya M, Saliganti V, Dass G, Kapila S. Dietary supplementation of milk fermented with probiotic Lactobacillus fermentum enhances systemic immune response and antioxidant capacity in aging mice. Nutr Res 2014;34(11):968-81. doi:10.1016/j.nutres.2014.09.006.
Lewis JE, Hilditch JR, Wong CJ. Further psychometric property development of the Menopause-Specific Quality of Life questionnaire and development of a modified version, MENQOL-Intervention questionnaire. Maturitas. 2005;50(3):209-21. doi:10.1016/j.maturitas.2004.06.015.
Sarit-apirak S, Manonai J, Theppisai U, Khanacharoen A, Udomsubpayakul U, Chittacharoen A. Quality of life and urinary incontinence in women. Thai J Obstet Gynaecol. 2003;15(3):191-4.
