Top

Published in:

20-07-2022 | Insulins | Original Contribution

Efficacy of multi-strain probiotic along with dietary and lifestyle modifications on polycystic ovary syndrome: a randomised, double-blind placebo-controlled study

Authors: Ishwarpreet Kaur, Vanita Suri, Naresh Sachdeva, Satya Vati Rana, Bikas Medhi, Nancy Sahni, Jayesh Ahire, Amarjeet Singh

Published in: European Journal of Nutrition | Issue 8/2022

Abstract

Purpose

Effect of multi-strain probiotic along with dietary and lifestyle modifications in the management of polycystic ovary syndrome (PCOS) has rarely been reported. We thus aimed to investigate the effect of multi-strain probiotic (Lactobacillus acidophilus UBLA-34, L. rhamnosus UBLR-58, L. reuteri UBLRu-87 (each of 2 billion colony forming units (CFU)); L. plantarum UBLP-40, L. casei UBLC-42, L. fermentum UBLF-31, Bifidobacterium bifidum UBBB-55 (each of 1 billion CFU) and fructo-oligosaccharides (100 mg)) and dietary and lifestyle modifications on restoration of menstrual regularity, weight reduction, metabolic and hormonal profile in women with PCOS.

Methods

A 104 participants (age 18–40 years) were randomly allocated to receive probiotic or placebo capsules for 6 months. Baseline and end line assessment were performed for menstrual cycle regularity, ultrasonography scan for ovaries, total testosterone, dehydroepiandrosterone (DHEAS), insulin, luteinizing hormone/follicle stimulating hormone (LH/FSH) ratio, fasting blood sugar (FBS), homeostatic model assessment-insulin resistance (HOMA-IR), weight reduction, waist-/hip circumference (WC, HC), waist to hip ratio (WHR), and body mass index (BMI). Plasma lipopolysaccharide and effect of intervention on quality of life was investigated. Diet and exercise were controlled during the trial.

Results

Probiotic supplement along with dietary and lifestyle modifications significantly regularised menstrual cycle (p 0.023), improved levels of total testosterone (p 0.043), WC (p 0.030), WHR (p 0.027) and menstrual domain of quality of life (p 0.034) as compared to placebo. No adverse events related to study were reported.

Conclusion

Multi-strain probiotic along with dietary and lifestyle modifications were effective in the management of PCOS.

Trial registration

CTRI: CTRI/2016/07/007086, dated 13 July 2016.

Available only for authorised users

Teede H, Deeks A, Moran L (2010) Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med 8:41. https://doi.org/10.1186/1741-7015-8-41CrossRefPubMedPubMedCentral

Bulsara JP, Patel P, Soni A, Acharya S (2021) A review: brief insight into polycystic ovarian syndrome. Endocrine Metabolic Sci 3:100085. https://doi.org/10.1016/j.endmts.2021.100085CrossRef

Aversa A, La Vignera S, Rago R, Gambineri A, Nappi RE, Calogero AE, Ferlin A (2020) Fundamental concepts and novel aspects of polycystic ovarian syndrome: expert consensus resolutions. Front Endocrinol 11:516. https://doi.org/10.3389/fendo.2020.00516CrossRef

Global Burden of Disease (GBD) (2019) http://www.healthdata.org/results/gbd_summaries/2019/polycystic-ovarian-syndrome-level-4-cause

Ganie MA, Vasudevan V, Wani IA, Baba MS, Arif T, Rashid A (2019) Epidemiology, pathogenesis, genetics & management of polycystic ovary syndrome in India. Indian J Med Res 150(4):333–344. https://doi.org/10.4103/ijmr.IJMR_1937_17CrossRefPubMedPubMedCentral

Kodama S, Torrealday S (2021) Pharmacologic treatments for PCOS patients. Clin Obstet Gynecol 64(1):55–64. https://doi.org/10.1097/GRF.0000000000000597CrossRefPubMed

Luque-Ramírez M, Escobar-Morreale HF (2015) Targets to treat androgen excess in polycystic ovary syndrome. Expert Opin Ther Targets 19(11):1545–1560. https://doi.org/10.1517/14728222.2015.1075511CrossRefPubMed

Jang YS, Lee ES, Kim YK (2021) Venous thromboembolism associated with combined oral contraceptive use: a single-institution experience. Obstet Gynecol Sci 64(4):337–344. https://doi.org/10.5468/ogs.20374CrossRefPubMedPubMedCentral

Lashen H (2010) Role of metformin in the management of polycystic ovary syndrome. Ther Adv Endocrinol Metab 1(3):117–128. https://doi.org/10.1177/2042018810380215CrossRefPubMedPubMedCentral

10.

Cree-Green M (2017) Worldwide dissatisfaction with the diagnostic process and initial treatment of PCOS. J Clin Endocrinol Metab 102(2):375–378. https://doi.org/10.1210/jc.2016-3808CrossRefPubMedPubMedCentral

11.

Aly JM, Decherney AH (2021) Lifestyle modifications in PCOS. Clin Obstet Gynecol 64(1):83–89. https://doi.org/10.1097/GRF.0000000000000594CrossRefPubMed

12.

Abdolahian S, Tehrani FR, Amiri M, Ghodsi D, Yarandi RB, Jafari M, Majd HA, Nahidi F (2020) Effect of lifestyle modifications on anthropometric, clinical, and biochemical parameters in adolescent girls with polycystic ovary syndrome: a systematic review and meta-analysis. BMC Endocr Disord 20(1):71. https://doi.org/10.1186/s12902-020-00552-1CrossRefPubMedPubMedCentral

13.

Patti AM, Al-Rasadi K, Giglio RV, Nikolic D, Mannina C, Castellino G, Chianetta R, Banach M, Cicero AF, Lippi G, Montalto G (2018) Natural approaches in metabolic syndrome management. Arch Med Sci 14(2):422–441. https://doi.org/10.5114/aoms.2017.68717CrossRefPubMed

14.

McFarland LV (2014) Use of probiotics to correct dysbiosis of normal microbiota following disease or disruptive events: a systematic review. BMJ Open 4(8):e005047. https://doi.org/10.1136/bmjopen-2014-005047CrossRefPubMedPubMedCentral

15.

Kazemi A, Soltani S, Ghorabi S, Keshtkar A, Daneshzad E, Nasri F, Mazloomi SM (2020) Effect of probiotic and synbiotic supplementation on inflammatory markers in health and disease status: A systematic review and meta-analysis of clinical trials. Clin Nutr 39(3):789–819. https://doi.org/10.1016/j.clnu.2019.04.004CrossRefPubMed

16.

Jandhyala SM, Talukdar R, Subramanyam C, Vuyyuru H, Sasikala M, Nageshwar Reddy D (2015) Role of the normal gut microbiota. World J Gastroenterol 21(29):8787–8803. https://doi.org/10.3748/wjg.v21.i29.8787CrossRefPubMedPubMedCentral

17.

Singh R, Zogg H, Wei L, Bartlett A, Ghoshal UC, Rajender S, Ro S (2021) Gut microbial dysbiosis in the pathogenesis of gastrointestinal dysmotility and metabolic disorders. J Neurogastroenterol Motil 27(1):19–34. https://doi.org/10.5056/jnm20149CrossRefPubMedPubMedCentral

18.

Rizk MG, Thackray VG (2021) Intersection of polycystic ovary syndrome and the gut microbiome. J Endocr Soc. https://doi.org/10.1210/jendso/bvaa177CrossRefPubMed

19.

Torres PJ, Siakowska M, Banaszewska B (2018) Gut microbial diversity in women with polycystic ovary syndrome correlates with hyperandrogenism. J Clin Endocrinol Metab 103:1502–1511. https://doi.org/10.1210/jc.2017-02153CrossRefPubMedPubMedCentral

20.

Sudha MR, Maurya AK (2012) Effect of oral supplementation of the probiotic capsule UB-01BV in the treatment of patients with bacterial vaginosis. Benef Microbes 3(2):151–155. https://doi.org/10.3920/BM2011.0054CrossRefPubMed

21.

Venkataraman R, Madempudi RS, Neelamraju J, Ahire JJ, Vinay HR, Lal A, Thomas G, Stephen S (2021) Effect of multi-strain probiotic formulation on students facing examination stress: a double-blind, placebo-controlled study. Probiot Antimicrob Proteins 13(1):12–18. https://doi.org/10.1007/s12602-020-09681-4CrossRef

22.

Sudha MR, Ahire JJ, Jayanthi N, Tripathi A, Nanal S (2019) Effect of multi-strain probiotic (UB0316) in weight management in overweight/obese adults: a 12-week double blind, randomised, placebo-controlled study. Benef Microbes 10(8):855–866. https://doi.org/10.3920/BM2019.0052CrossRefPubMed

23.

Madempudi RS, Ahire JJ, Neelamraju J, Tripathi A, Nanal S (2019) Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study. PLoS ONE 14(11):e0225168. https://doi.org/10.1371/journal.pone.0225168CrossRefPubMedPubMedCentral

24.

Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group (2004) Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril 81(1):19–25. https://doi.org/10.1016/j.fertnstert.2003.10.004CrossRef

25.

Cronin L, Guyatt G, Griffith L, Wong E, Azziz R, Futterweit W, Cook D, Dunaif A (1998) Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS). J Clin Endocrinol Metab 83(6):1976–1987. https://doi.org/10.1210/jcem.83.6.4990CrossRefPubMed

26.

Bazarganipour F, Ziaei S, Montazeri A, Foroozanfard F, Faghihzadeh S (2013) Iranian version of modified polycystic ovary syndrome health-related quality of Life questionnaire: Discriminant and convergent validity. Iran J Reprod Med 11(9):753–760PubMedPubMedCentral

27.

Nagpal M, De D, Handa S, Pal A, Sachdeva N (2016) Insulin resistance and metabolic syndrome in young men with acne. JAMA Dermatol 152(4):399–404. https://doi.org/10.1001/jamadermatol.2015.4499CrossRefPubMed

28.

Legro RS, Dodson WC, Kris-Etherton PM, Kunselman AR, Stetter CM, Williams NI, Gnatuk CL, Estes SJ, Fleming J, Allison KC, Sarwer DB, Coutifaris C, Dokras A (2015) Randomized controlled trial of preconception interventions in infertile women with polycystic ovary syndrome. J Clin Endocrinol Metab 100(11):4048–4058. https://doi.org/10.1210/jc.2015-2778CrossRefPubMedPubMedCentral

29.

Parker J, O’Brien C, Hawrelak J (2022) A narrative review of the role of gastrointestinal dysbiosis in the pathogenesis of polycystic ovary syndrome. Obstet Gynecol Sci 65(1):14–28. https://doi.org/10.5468/ogs.21185CrossRefPubMedPubMedCentral

30.

Ghosh S, Whitley CS, Haribabu B, Jala VR (2021) Regulation of intestinal barrier function by microbial metabolites. Cell Mol Gastroenterol Hepatol 11(5):1463–1482. https://doi.org/10.1016/j.jcmgh.2021.02.007CrossRefPubMedPubMedCentral

31.

Al Bander Z, Nitert MD, Mousa A, Naderpoor N (2020) The gut microbiota and inflammation: an overview. Int J Environ Res Public Health 17(20):7618. https://doi.org/10.3390/ijerph17207618CrossRefPubMedCentral

32.

Cozzolino M, Vitagliano A, Pellegrini L, Chiurazzi M, Andriasani A, Ambrosini G, Garrido N (2020) Therapy with probiotics and synbiotics for polycystic ovarian syndrome: a systematic review and meta-analysis. Eur J Nutr 59(7):2841–2856. https://doi.org/10.1007/s00394-020-02233-0CrossRefPubMed

33.

Tabrizi R, Ostadmohammadi V, Akbari M, Lankarani KB, Vakili S, Peymani P, Karamali M, Kolahdooz F, Asemi Z (2022) The effects of probiotic supplementation on clinical symptom, weight loss, glycemic control, lipid and hormonal profiles, biomarkers of inflammation, and oxidative stress in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials. Probiot Antimicrob Proteins 14(1):1–14. https://doi.org/10.1007/s12602-019-09559-0CrossRef

34.

Darvishi S, Rafraf M, Asghari-Jafarabadi M, Farzadi L (2021) Synbiotic supplementation improves metabolic factors and obesity values in women with polycystic ovary syndrome independent of affecting apelin levels: a randomized double-blind placebo-controlled Clinical trial. Int J Fertil Steril 15(1):51–59. https://doi.org/10.22074/ijfs.2021.6186

35.

Hahn S, Janssen OE, Tan S, Pleger K, Mann K, Schedlowski M, Kimmig R, Benson S, Balamitsa E, Elsenbruch S (2005) Clinical and psychological correlates of quality-of-life in polycystic ovary syndrome. Eur J Endocrinol 153(6):853–860. https://doi.org/10.1530/eje.1.02024CrossRefPubMed

36.

Khairnar MR, Wadgave U, Shimpi PV (2016) Updated BG Prasad socioeconomic classification for 2016. J Indian Assoc Public Health Dent 14:469–70. https://www.jiaphd.org/text.asp?2016/14/4/469/195832

Title: Efficacy of multi-strain probiotic along with dietary and lifestyle modifications on polycystic ovary syndrome: a randomised, double-blind placebo-controlled study
Authors: Ishwarpreet Kaur
Vanita Suri
Naresh Sachdeva
Satya Vati Rana
Bikas Medhi
Nancy Sahni
Jayesh Ahire
Amarjeet Singh
Publication date: 20-07-2022
Publisher: Springer Berlin Heidelberg
Keywords: Insulins
Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
Insulins
Testosterone
Lifestyle Modifications
Published in: European Journal of Nutrition / Issue 8/2022
Print ISSN: 1436-6207
Electronic ISSN: 1436-6215
DOI: https://doi.org/10.1007/s00394-022-02959-z

Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Reserve your place

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin

Prof. Florian Limbourg

Prof. Anoop Chauhan

Developed by: Springer Medicine

Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Pediatric Cardiology Video

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

Cardiopulmonary Comorbidity Video

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Valvular Heart Disease Video

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

Watch now

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits

Illustration of figure on mountain summit/© Orapun / Stock.adobe.com, STEP AAG HeroTeaserCollection image/© Tarek / Generated with AI / Stock.adobe.com, ACC 2024 Pediatric and Congenital Heart Disease: Year in Review/© 2024 American College of Cardiology, ACC 2024 Pulmonary Vascular Disease: Year in Review/© 2024 American College of Cardiology, ACC 2024 Valvular Heart Disease: Year in Review/© 2024 American College of Cardiology, ACC 2024 HF and Cardiomyopathies: Year in Review/© 2024 American College of Cardiology, Woman out walking/© Seventyfour / stock.adobe.com (symbolic image with model), Woman checking smartwatch /© saltdium / stock.adobe.com (symbolic image with model), Cardiac catheterization/© Damian / stock.adobe.com

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

Please log in to get access to this content

Other articles of this Issue 8/2022

Prospective dietary polyunsaturated fatty acid intake is associated with trajectories of fatty liver disease: an 8 year follow-up study from adolescence to young adulthood

Normal and unusual days for dietary intake during the 12 months after a breast cancer diagnosis in women

Association between dietary intake networks identified through a Gaussian graphical model and the risk of cancer: a prospective cohort study

Oligosaccharides from agar extends lifespan through activation of unfolded protein response via SIR-2.1 in Caenorhabditis elegans

Correction to: Long‑term effect of a dietary intervention with two‑healthy dietary approaches on food intake and nutrient density in coronary patients: results from the CORDIOPREV trial

Free docosahexaenoic acid promotes ferroptotic cell death via lipoxygenase dependent and independent pathways in cancer cells

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

Highlights from the ACC 2024 Congress

ACC 2024 Congress Coverage