Synbiotic-Containing Bacillus coagulans (GBI-30) and the Effects on Glycemic Control, Androgen Hormones and Anthropometric Indices in Women with Polycystic Ovarian Syndrome
-
Zahra Hariri
,
Zahra Yari
,
Maryam Nilghaz
,
Monirsadat Mirhoseini
,
Sedighe Hoseini
,
Khadijeh Abhari
,
Golbon Sohrab
Abstract
Background: We aimed to investigate the effect of synbiotic supplement-containing spore-forming Bacillus coagulans (GBI-30) on the glycemic, hormonal and anthropometric parameters in patients with PCOS.
Methods: In this randomized, triple-blind, placebo-controlled trial, 72 patients with PCOS were randomly and equally assigned to receive a daily sachet of synbiotic (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnosus, Lactobacillus helveticus, and fructooligosaccharide (FOS)) or placebo for 12 wk. Glycemic, hormonal and anthropometric parameters were measured at baseline and after the 12-week of intervention.
Results: At the end, 60 patients completed the study. After adjustment for potential confounders, significant decrease in insulin (−3.38±20.20 vs. +2.33, P=0.042), homeostatic model assessment for insulin resistance (HOMA-IR) (−0.43±3.61 vs. +0.73 ± 2.91, P=0.044) and dehydroepiandrosterone sulfate (DHEAS) (−1.47±6.62 vs. + 0.03 ± 2.06, P=0.047) was observed in the intervention group compared to the control group. Supplementation with synbiotic failed to show a significant effect on anthropometric parameters and fasting blood sugar.
Conclusion: Overall, 12 wk supplementation with synbiotic-containing Bacillus coagulans (GBI-30) can offer additional benefit to lifestyle intervention on metabolic status of women with polycystic ovarian syndrome.
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17. Majid H, Masood Q, Khan AH (2017). Homeostatic Model Assessment for Insulin Resistance (HOMA-IR): A Better Marker for Evaluating Insulin Resistance Than Fasting Insulin in Women with Polycystic Ovarian Syndrome. J Coll Physicians Surg Pak, 27 (3):123-126.
18. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC (1985). Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia, 28 (7):412-9.
19. Katz A, Nambi SS, Mather K, et al (2000). Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab, 85 (7):2402-10.
20. Hariri Z, Yari Z, Hoseini S, Mehrnami A, Abhari K, Sohrab G (2023). Effects of Synbiotic-Containing Bacillus coagulans (GBI-30) on the Cardiovascular Status of Patients With Polycystic Ovary Syndrome: A Triple-blinded, Randomized, Placebo-controlled Study. Clin Ther, 45 (10):e193-e199.
21. Velayati A, Kareem I, Sedaghat M, et al (2023). Does symbiotic supplementation which contains Bacillus Coagulans Lactobacillus rhamnosus, Lactobacillus acidophilus and fructooligosaccharide has favourite effects in patients with type-2 diabetes? A randomised, double-blind, placebo-controlled trial. Arch Physiol Biochem, 129 (6):1211-1218.
22. Abhari K, Saadati S, Yari Z, et al (2020). The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial. Clin Nutr ESPEN, 39:53-60.
23. Hattori K, Orisaka M, Fukuda S, et al (2018). Luteinizing Hormone Facilitates Antral Follicular Maturation and Survival via Thecal Paracrine Signaling in Cattle. Endocrinology, 159 (6):2337-2347.
24. Hartstra AV, Bouter KE, Bäckhed F, Nieuwdorp M (2015). Insights into the role of the microbiome in obesity and type 2 diabetes. Diabetes Care, 38 (1):159-65.
25. Gao Z, Yin J, Zhang J, et al (2009). Butyrate improves insulin sensitivity and increases energy expenditure in mice. Diabetes, 58 (7):1509-17.
26. Wellen KE, Hotamisligil GS (2005). Inflammation, stress, and diabetes. J Clin Invest, 115 (5):1111-9.
27. Shimizu K, Ogura H, Asahara T, et al (2013). Probiotic/synbiotic therapy for treating critically ill patients from a gut microbiota perspective. Dig Dis Sci, 58 (1):23-32.
28. Samimi M, Dadkhah A, Haddad Kashani H, Tajabadi-Ebrahimi M, Seyed Hosseini E, Asemi Z (2019). The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial. Probiotics Antimicrob Proteins, 11 (4):1355-1361.
29. Miao C, Guo Q, Fang X, et al (2021). Effects of probiotic and synbiotic supplementation on insulin resistance in women with polycystic ovary syndrome: a meta-analysis. J Int Med Res, 49 (7):3000605211031758.
30. Karimi E, Moini A, Yaseri M, Shirzad N, Sepidarkish M, Hossein-Boroujerdi M, Hosseinzadeh-Attar MJ (2018). Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial. Br J Nutr, 119 (4):398-406.
31. Abbott DH, Dumesic DA, Levine JE (2019). Hyperandrogenic origins of polycystic ovary syndrome - implications for pathophysiology and therapy. Expert Rev Endocrinol Metab, 14 (2):131-143.
32. Karamali M, Eghbalpour S, Rajabi S, et al (2018). Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Arch Iran Med, 21 (1):1-7.
33. Nasri K, Jamilian M, Rahmani E, et al (2018). The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. BMC Endocr Disord, 18 (1):21.
34. Shamasbi SG, Ghanbari-Homayi S, Mirghafourvand M (2020). The effect of probiotics, prebiotics, and synbiotics on hormonal and inflammatory indices in women with polycystic ovary syndrome: a systematic review and meta-analysis. Eur J Nutr, 59 (2):433-450.
2. Teede HJ, Misso ML, Costello MF, et al (2018). Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril, 110(3):364-379.
3. Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO (2016). The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod, 31 (12):2841-2855.
4. Witchel SF, Oberfield SE, Peña AS (2019). Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls. J Endocr Soc, 3 (8):1545-1573.
5. Azziz R, Carmina E, Chen Z, et al (2016). Polycystic ovary syndrome. Nat Rev Dis Primers, 2:16057.
6. Zhao X, Ni R, Li L, Mo Y, Huang J, Huang M, Azziz R, Yang D (2011). Defining hirsutism in Chinese women: a cross-sectional study. Fertil Steril, 96 (3):792-6.
7. Keen MA, Shah IH, Sheikh G (2017). Cutaneous Manifestations of Polycystic Ovary Syndrome: A Cross-Sectional Clinical Study. Indian Dermatol Online J, 8 (2):104-110.
8. Pugeat M, Ducluzeau PH (1999). Insulin resistance, polycystic ovary syndrome and metformin. Drugs, 58 Suppl 1:41-6; discussion 75-82.
9. Kim YA, Keogh JB, Clifton PM (2018). Probiotics, prebiotics, synbiotics and insulin sensitivity. Nutr Res Rev, 31 (1):35-51.
10. Guo Y, Qi Y, Yang X, Zhao L, Wen S, Liu Y, Tang L (2016). Association between Polycystic Ovary Syndrome and Gut Microbiota. PLoS One, 11 (4):e0153196.
11. Li Y, Tan Y, Xia G, Shuai J (2023). Effects of probiotics, prebiotics, and synbiotics on polycystic ovary syndrome: a systematic review and meta-analysis. Crit Rev Food Sci Nutr, 63 (4):522-538.
12. Vlasova AN, Kandasamy S, Chattha KS, Rajashekara G, Saif LJ (2016). Comparison of probiotic lactobacilli and bifidobacteria effects, immune responses and rotavirus vaccines and infection in different host species. Vet Immunol Immunopathol, 172:72-84.
13. Jäger R, Purpura M, Farmer S, Cash HA, Keller D (2018). Probiotic Bacillus coagulans GBI-30, 6086 Improves Protein Absorption and Utilization. Probiotics Antimicrob Proteins, 10 (4):611-615.
14. (2004). Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril, 81 (1):19-25.
15. Centers for Disease Control Prevention; Hyattsville MUDoH, Services H (2016). National Health and Nutrition Examination Survey (NHANES): Anthropometry Procedures Manual.2015-2016.
16. Ogden CL, Carroll MD, Flegal KM (2008). High body mass index for age among US children and adolescents, 2003-2006. JAMA, 299 (20):2401-5.
17. Majid H, Masood Q, Khan AH (2017). Homeostatic Model Assessment for Insulin Resistance (HOMA-IR): A Better Marker for Evaluating Insulin Resistance Than Fasting Insulin in Women with Polycystic Ovarian Syndrome. J Coll Physicians Surg Pak, 27 (3):123-126.
18. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC (1985). Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia, 28 (7):412-9.
19. Katz A, Nambi SS, Mather K, et al (2000). Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab, 85 (7):2402-10.
20. Hariri Z, Yari Z, Hoseini S, Mehrnami A, Abhari K, Sohrab G (2023). Effects of Synbiotic-Containing Bacillus coagulans (GBI-30) on the Cardiovascular Status of Patients With Polycystic Ovary Syndrome: A Triple-blinded, Randomized, Placebo-controlled Study. Clin Ther, 45 (10):e193-e199.
21. Velayati A, Kareem I, Sedaghat M, et al (2023). Does symbiotic supplementation which contains Bacillus Coagulans Lactobacillus rhamnosus, Lactobacillus acidophilus and fructooligosaccharide has favourite effects in patients with type-2 diabetes? A randomised, double-blind, placebo-controlled trial. Arch Physiol Biochem, 129 (6):1211-1218.
22. Abhari K, Saadati S, Yari Z, et al (2020). The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial. Clin Nutr ESPEN, 39:53-60.
23. Hattori K, Orisaka M, Fukuda S, et al (2018). Luteinizing Hormone Facilitates Antral Follicular Maturation and Survival via Thecal Paracrine Signaling in Cattle. Endocrinology, 159 (6):2337-2347.
24. Hartstra AV, Bouter KE, Bäckhed F, Nieuwdorp M (2015). Insights into the role of the microbiome in obesity and type 2 diabetes. Diabetes Care, 38 (1):159-65.
25. Gao Z, Yin J, Zhang J, et al (2009). Butyrate improves insulin sensitivity and increases energy expenditure in mice. Diabetes, 58 (7):1509-17.
26. Wellen KE, Hotamisligil GS (2005). Inflammation, stress, and diabetes. J Clin Invest, 115 (5):1111-9.
27. Shimizu K, Ogura H, Asahara T, et al (2013). Probiotic/synbiotic therapy for treating critically ill patients from a gut microbiota perspective. Dig Dis Sci, 58 (1):23-32.
28. Samimi M, Dadkhah A, Haddad Kashani H, Tajabadi-Ebrahimi M, Seyed Hosseini E, Asemi Z (2019). The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial. Probiotics Antimicrob Proteins, 11 (4):1355-1361.
29. Miao C, Guo Q, Fang X, et al (2021). Effects of probiotic and synbiotic supplementation on insulin resistance in women with polycystic ovary syndrome: a meta-analysis. J Int Med Res, 49 (7):3000605211031758.
30. Karimi E, Moini A, Yaseri M, Shirzad N, Sepidarkish M, Hossein-Boroujerdi M, Hosseinzadeh-Attar MJ (2018). Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial. Br J Nutr, 119 (4):398-406.
31. Abbott DH, Dumesic DA, Levine JE (2019). Hyperandrogenic origins of polycystic ovary syndrome - implications for pathophysiology and therapy. Expert Rev Endocrinol Metab, 14 (2):131-143.
32. Karamali M, Eghbalpour S, Rajabi S, et al (2018). Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Arch Iran Med, 21 (1):1-7.
33. Nasri K, Jamilian M, Rahmani E, et al (2018). The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. BMC Endocr Disord, 18 (1):21.
34. Shamasbi SG, Ghanbari-Homayi S, Mirghafourvand M (2020). The effect of probiotics, prebiotics, and synbiotics on hormonal and inflammatory indices in women with polycystic ovary syndrome: a systematic review and meta-analysis. Eur J Nutr, 59 (2):433-450.
| Files | ||
| Issue | Vol 54 No 7 (2025) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijph.v54i7.19160 | |
| Keywords | ||
| Polycystic ovary syndrome Bacillus coagulans Synbiotics Insulin resistance Hyperandrogenism | ||
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How to Cite
1.
Hariri Z, Yari Z, Nilghaz M, Mirhoseini M, Hoseini S, Abhari K, Sohrab G. Synbiotic-Containing Bacillus coagulans (GBI-30) and the Effects on Glycemic Control, Androgen Hormones and Anthropometric Indices in Women with Polycystic Ovarian Syndrome. Iran J Public Health. 2025;54(7):1540-1550.
