Effects of Bifidobacterium longum longum 35624® on the Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome: Results of the Multicenter Observational Program SAGA

Aim: to evaluate the effects of the probiotic Symbiosys Alflorex (Bifidobacterium longum longum 35624®) on the symptoms and quality of life in patients with irritable bowel syndrome (IBS).

Materials and methods. A multicenter, observational program (SAGA) was conducted to evaluate the effects of Symbiosys Alflorex on symptoms and quality of life in patients with IBS, which enrolled 3,116 patients and 246 physicians from 48 cities of Russia. Eligible patients were diagnosed with IBS according to the Rome IV Criteria and clinical guidelines of the Russian Association of Gastroenterology and the Association of Colorectal Surgeons of Russia. Patients received standard-of-care treatment and add-on therapy with Symbiosys Alflorex 1 capsule once daily for 28 days, followed by Symbiosys Alflorex alone for 2 months. The intensity of symptoms and severity of IBS were assessed using the 7 Symptoms in 7 Days (“7 × 7”) and the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) questionnaires, respectively. The Irritable Bowel Syndrome Quality of Life (IBS-QоL) questionnaire was used to assess the quality of life. Stool abnormalities were assessed using the Bristol Stool Scale.

Results. After the course of standard-of-care treatment and add-on therapy with Symbiosys Alflorex, 25.8 % of patients achieved clinical remission. After 3 months of probiotic treatment, 76.9 % of patients achieved clinical remission. A significant decrease in the “7 × 7” score was observed, with the mean total score decreasing from 15.8 to 9.77 after the main treatment course and to 3.44 by the end of the study. Stool consistency became normal in 40.1 % of patients by the end of the first month and in 76.8 % after 3 months of follow-up. Changes in the IBS-QoL score showed a significant improvement in the quality of life.

Conclusions. Add-on treatment with Symbiosys Alflorex 1 capsule once daily for 3 months helps to improve IBS symptoms and quality of life of patients. Symbiosys Alflorex has a favorable safety profile.

1. Oka P., Parr H., Barberio B., Black C.J., Sava rino E.V., Ford A.C. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: A systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020;5(10):908–17. DOI: 10.1016/S24681253(20)30217-X

2. Lacy B.E., Mearin F., Chang L., Chey W.D., Lembo A.J., Simren M., et al. Bowel disorders. Gastroenterology. 2016;150(6):1393–407e5. DOI: 10.1053/j.gastro.2016.02.031

3. Barbara G., Feinle-Bisset C., Ghoshal U.C., Santos H., Vanner S.J., Vergnolle N., et al. The Intestinal microenvironment and functional gastrointestinal disorders. Gastroenterology. 2016;150(6):1305–18e8. DOI: 10.1053/j.gastro.2016.02.028

4. Baj A., Moro E., Bistoletti M., Orlandi V., Crema F., Giaroni C. Glutamatergic signaling along the microbiota-gut-brain axis. Int J Mol Sci. 2019;20(6):1482. DOI: 10.3390/ijms20061482

5. Cryan J.F., O'Riordan K.J., Cowan C.S.M., Sandhu K.V., Bastiaanssen T.F.S., Boehme M., et al. The microbiota-gut-brain axis. Physiol Rev. 2019;99(4):1877–2013. DOI: 10.1152/physrev.00018.201

6. Margolis K.G., Cryan J.F., Mayer E.A. The microbiota-gut-brain axis: From motility to mood. Gastroenterology. 2021;160(5):1486–501. DOI: 10.1053/j.gastro.2020.10.066

7. Ivashkin V.T., Maev I.V., Shelygin Yu.A., Baranskaya E.K., Belous S.S., Belousova E.A., et al. Diagnosis and treatment of irritable bowel syndrome: Clinical recommendations of the Russian Gastroenterological Association and Association of Coloproctologists of Russia. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2021;31(5):74–95. (In Russ.). DOI: 10.22416/13824376-2021-31-5-74-95

8. Camilleri M., Ford A.C. Pharmacotherapy for irri table bowel syndrome. J Clin Med. 2017;6(11):101. DOI: 10.3390/jcm6110101

9. Guarner F., Sanders M.E., Szajewska H., Cohen H., Eliakim R., Herrera-deGuise C., et al. World Gastroenterology Organisation Global Guidelines: Probiotics and prebiotics. J Clin Gastroenterol. 2024;58(6):533–53. DOI: 10.1097/MCG.0000000000002002

10. Ivashkin V.T., Maev I.V., Abdulganieva D.I., Alek seenko S.A., Gorelov A.V., Zakharova I.N., et al. Prac tical Recommendations of Scientific Society for the Study of Human Microbiome and the Russian Gastroenterological Association on use of probiotics, prebiotics, synbiotics and functional foods in treatment and prevention of gastroenterological diseases in children and adults. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2021;31(2):65–91. (In Russ.). DOI: 10.22416/13824376-2021-31-2-65-91

11. Ford A.C., Harris L.A., Lacy B.E., Quigley E.M.M., Moayyedi P. Systematic review with meta-analysis: The efficacy of prebiotics, probiotics, synbiotics and antibiotics in irritable bowel syndrome. Aliment Pharmacol Ther. 2018;48(10):1044–60. DOI: 10.1111/apt.15001

12. McFarland L.V., Karakan T., Karatas A. Strain-specific and outcome-specific efficacy of probiotics for the treatment of irritable bowel syndrome: A systematic review and meta-analysis. EClinicalMedicine. 2021;41:101154. DOI: 10.1016/j.eclinm.2021.101154

13. Pittayanon R., Lau J.T., Yuan Y., Leontiadis G.I., Tse F., Surette M., et al. Gut microbiota in patients with irritable bowel syndrome — A systematic review. Gastroenterology. 2019;157(1):97–108. DOI: 10.1053/j.gastro.2019.03.049

14. Duan R., Zhu S., Wang B., Duan L. Alterations of gut microbiota in patients with irritable bowel syndrome based on 16S rRNA-targeted sequencing: A systematic review. Clin Transl Gastroenterol. 2019;10(2):e00012. DOI: 10.14309/ctg.0000000000000012

15. Maharshak N., Ringel Y., Katibian D., Lundqvist A., Sartor R.B., Carroll I.M., et al. Fecal and mucosa-associated intestinal microbiota in patients with diarrhea-predominant irritable bowel syndrome. Dig Dis Sci. 2018;63(7):1890–9. DOI: 10.1007/s10620-018-5086-4

16. Zhong W., Lu X., Shi H., Zhao G., Song Y., Wang Y., et al. Distinct microbial populations exist in the mucosa-associated microbiota of diarrhea predominant irritable bowel syndrome and ulcerative colitis. J Clin Gastroenterol. 2019;53(9):660–72. DOI: 10.1097/MCG.0000000000000961

17. Zhuang X., Xiong L., Li L., Li M., Chen M. Alterations of gut microbiota in patients with irritable bowel syndrome: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2017;32(1):28–38. DOI: 10.1111/jgh.13471

18. Wang L., Alammar N., Singh R., Nanavati J., Song Y., Chaudhary R., et al. Gut microbial dysbiosis in the irritable bowel syndrome: A systematic review and meta-analysis of case-control studies. J Acad Nutr Diet. 2020;120(4):565–86. DOI: 10.1016/j.jand.2019.05.015

19. Bu Z., Ye X., Huang B., Liu R., Peng L. Bifidobac teria was decreased in adult patients with irritable bowel syndrome based on PCR and bacterial culture: A systematic review and meta-analysis. Turk J Gastroenterol. 2022;33(5):368–76. DOI: 10.5152/tjg.2022.21543

20. Schiavi E., Gleinser M., Molloy E., Groeger D., Frei R., Ferstl R., et al. The surface-associated exopolysaccharide of Bifidobacterium longum 35624 plays an essential role in dampening host proinflammatory responses and repressing local TH17 responses. Appl Environ Microbiol. 2016;82(24):7185–96. DOI: 10.1128/AEM.02238-16

21. Groeger D., O'Mahony L., Murphy E.F., Bourke J.F., Dinan T.G., Kiely B., et al. Bifidobacterium infantis 35624 modulates host inflammatory processes beyond the gut. Gut Microbes. 2013;4(4):325–39. DOI: 10.4161/gmic.25487

22. Likert R. A technique for the measurement of attitudes. Archives of Psychology. 1932;22(140):55. URL: https://legacy.voteview.com/pdf/Likert_1932.pdf

23. Sabaté J.M., Iglicki F. Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome. World J Gastroenterol. 2022;28(7):732–44. DOI: 10.3748/wjg.v28.i7.732