Clinical efficacy of a modern probiotic for the correction of intestinal microflora in patients with irritable bowel syndrome with diarrhea and antibiotic-associated diarrhea
Abstract
Despite the fact that dietary supplements (DS) are not medicines, an increasing number of publications testify to the effectiveness of probiotics consumed with food in the complex treatment and prevention of a number of diseases of the gastrointestinal tract, including irritable bowel syndrome (IBS) and antibiotic-associated diarrhea (AAD).
The purpose of the study was to evaluate the effectiveness of the complex probiotic in the relief of diarrheal syndrome associated with intestinal microbiota dysbiosis in patients with IBS with diarrhea and AAD.
Material and methods. The study included 54 patients (31 with IBS with diarrhea and 23 with idiopathic AAD) aged 18 to 50 years. All patients included in the study were prescribed 1 capsule (350 mg) of the DS Neobiotic Lactobalance® per day for 21 days. One capsule contains: bifidobacteria (Bifidobacterium longum CBT BG7, Bifidobacterium lactis CBT BL3 Bifidobacterium bifidum CBT BF3), lactobacilli (Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5), lactic acid bacteria (Streptococcus thermophilus CBT ST3), fructooligosaccharides, vitamin C. The daily intake of bifidobacteria was 8.7×108 CFU, lactobacilli – 6.1×109 CFU, lactic acid bacteria 3.1×108 CFU and vitamin C – 12 mg. The severity of symptoms was assessed in points (from 0 to 7 points) using the GSRS questionnaire (Gastrointestinal Symptom Rating Scale). All patients underwent a microbiological analysis of feces with an assessment of the degree of dysbiosis before and after the administration of DS.
Results. In patients with IBS with diarrhea, the assessment of the manifestations of diarrheal syndrome according to the GSRS questionnaire decreased statistically significantly from 17 to 6 points (2.9 times), abdominal pain – from 12 to 4 points (3.0 times) and dyspeptic syndrome – from 8 to 3 points (in 2.7 times). In patients with AAD, also according to the GSRS questionnaire, the manifestations of diarrheal syndrome decreased statistically significantly from 13 to 3 points (4.3 times), abdominal pain – from 4 to 1 points (4.0 times) and dyspepsia syndrome – from 5 to 2 points (in 2.5 times). Against the background of DS intake, according to the data of bacteriological examination of feces, intestinal microbiota normalized by day 21 due to an increase in the number of lacto- and bifidobacteria (p≤0.05).
Conclusion. The study showed that the DS Neobiotic Lactobalance® contributes to the normalization of the intestinal microbiota and reduces the severity of clinical manifestations (diarrheal disorders or manifestations of diarrhea) in IBS and idiopathic AAD.
Keywords:probiotic; irritable bowel syndrome; antibiotic-associated diarrhea
Funding. The study was not sponsored.
Conflict of interest. The authors declare no conflict of interest.
Contribution. Concept and design of the study – Drozdov V.N.; collection of material – Astapovskii A.A.; processing of material – Khalaidzheva K.N., Solovieva S.A.; statistical processing – Drozdov V.N.; writing the text – Astapovskii A.A.; editing the text, approval of the final version of the article, responsibility for the integrity of all parts of the article – all authors.
For citation: Drozdov V.N., Shikh E.V., Astapovskii A.A., Khalaidzheva K.N., Solovieva S.A., Dorogun O.B. Clinical efficacy of a modern probiotic for the correction of intestinal microflora in patients with irritable bowel syndrome with diarrhea and antibiotic-associated diarrhea. Voprosy pitaniia [Problems of Nutrition]. 2023; 92 (4): 92–103. DOI: https://doi.org/10.33029/0042-8833-2023-92-4-92-103 (in Russian)
References
1. Vasant D.H., Paine P.A., Black C.J., Houghton L.A., Everitt H.A., Corsetti M., et al. British Society of Gastroenterology guidelines on the management of irritable bowel syndrome. Gut. 2021; 70 (7): 1214–40. DOI: https://doi.org/10.1136/gutjnl-2021-324598
2. Oka P., Parr H., Barberio B., Black C.J., Savarino 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: https://doi.org/10.1016/s2468-1253(20)30217-x
3. Ivashkin V.T., Shelygin Yu.A., Baranskaya E.K., Achkasov S.I., Belous S.S., Belousova E.A., et al. Irritable bowel syndrome. Koloproktologiya [Coloproctology]. 2022; 21 (1): 10–25. DOI: https://doi.org/10.33878/2073-7556-2022-21-1-10-25 (in Russian)
4. Maev I.V., Bordin D.S., Eremina E.U., Il’chishina T.A., Kaybysheva V.O., Osipenko M.F., et al. Irritable bowel syndrome. Modern aspects of epidemiology, pathogenesis and treatment (a review). Eksperimental’naya i klinicheskaya gastoenterologiya [Experimental and Clinical Gastroenterology]. 2018; (10): 68–73. (in Russian)
5. Nellesen D., Yee K., Chawla A., Lewis B.E., Carson R.T. A systematic review of the economic and humanistic burden of illness in irritable bowel syndrome and chronic constipation. J Manag Care Pharm. 2013; 19 (9): 755–64. DOI: https://doi.org/10.18553/jmcp.2013.19.9.755
6. Flacco M.E., Manzoli L., De Giorgio R., Gasbarrini A., Cicchetti A., Bravi F., et al. Costs of irritable bowel syndrome in European countries with universal healthcare coverage: a meta-analysis. Eur Rev Med Pharmacol Sci. 2019; 23 (7): 2986–3000. DOI: https://doi.org/10.26355/eurrev_201904_17580
7. Ballou S., McMahon C., Lee H.-N., Katon J., Shin A., Rangan V., et al. Effects of irritable bowel syndrome on daily activities vary among subtypes based on results from the IBS in America survey. Clin Gastroenterol Hepatol. 2019; 17 (12): 2471–8.e3. DOI: https://doi.org/10.1016/j.cgh.2019.08.016
8. Bakulin I.G., Avalueva E.B., Оrеshkо L.S., Sitkin S.I., Shevyakov M.A., Serkova M.Yu., et al. Diet therapy for irritable bowel syndrome. Terapevticheskiy arkhiv [Therapeutic Archive]. 2020; 92 (8): 118–27. DOI: https://doi.org/10.26442/00403660.2020.08.000759 (in Russian)
9. Ford A.C., Sperber A.D., Corsetti M., Camilleri M. Irritable bowel syndrome. Lancet. 2020; 396 (10 263): 1675–88. DOI: https://doi.org/10.1016/s0140-6736(20)31548-8
10. Distrutti E., Monaldi L., Ricci P., Fiorucci S. Gut microbiota role in irritable bowel syndrome: new therapeutic strategies. World J Gastroenterol. 2016; 22 (7): 2219–41. DOI: https://doi.org/10.3748/wjg.v22.i7.2219
11. Canakis A., Haroon M., Weber H.C. Irritable bowel syndrome and gut microbiota. Curr Opin Endocrinol Diabetes Obes. 2020; 27 (1): 28–35. DOI: https://doi.org/10.1097/med.0000000000000523
12. McFarland L.V., Ozen M., Dinleyici E.C., Goh S. Comparison of pediatric and adult antibiotic-associated diarrhea and Clostridium difficile infections. World J Gastroenterol. 2016; 22 (11): 3078. DOI: https://doi.org/10.3748/wjg.v22.i11.3078
13. Abad C.L., Safdar N. A review of Clostridioides difficile infection and antibiotic-associated diarrhea. Gastroenterol Clin North Am. 2021; 50 (2): 323–40. DOI: https://doi.org/10.1016/j.gtc.2021.02.010
14. Francino M.P. Antibiotics and the human gut microbiome: dysbioses and accumulation of resistances. Front Microbiol. 2016; 6: 1543. DOI: https://doi.org/10.3389/fmicb.2015.01543
15. Shapovalova M.M., Budnevsky A.V., Kravchenko A.Y., Drobysheva E.S., Ovsyannikov E.S. Pathogenesis, actual aspects of prevention and treatment of the antibiotic-associated diarrhoea. Arkhiv vnutrenney meditsiny [Archives of Internal Medicine]. 2018; 8 (6): 424–9. DOI: https://doi.org/10.20514/2226-6704-2018-8-6-424-429 (in Russian)
16. Selvaraj V., Alsamman M.A. Antibiotic-associated diarrhea beyond C. difficile: a scoping review. Brown Hospital Medicine. 2023; 2 (1). DOI: https://doi.org/10.56305/001c.39745
17. Gomez R., Fernandez S., Aspirot A., Punati J., Skaggs B., Mousa H., et al. Effect of amoxicillin/clavulanate on gastrointestinal motility in children. J Pediatr Gastroenterol Nutr. 2012; 54 (6): 780–4. DOI: https://doi.org/10.1097/mpg.0b013e31824204e4
18. Parkman H.P. Prokinetic agents for gastroparesis. In: R.W. McCallum, H.P. Parkman (eds). Gastroparesis. Academic Press, 2021: 323–39. DOI: https://doi.org/10.1016/B978-0-12-818586-5.00024-7 ISBN 9780128185865.
19. Song X., Bartlett J.G., Speck K., Naegeli A., Carroll K., Perl T.M. Rising economic impact of Clostridium difficile-associated disease in adult hospitalized patient population. Infect Control Hosp Epidemiol. 2008; 29 (9): 823–8. DOI: https://doi.org/10.1086/588756
20. Zhang S., Palazuelos-Munoz S., Balsells E.M., Nair H., Chit A., Kyaw M.H. Cost of hospital management of Clostridium difficile infection in United States – a meta-analysis and modelling study. BMC Infect Dis. 2016; 16: 447. DOI: https://doi.org/10.1186/s12879-016-1786-6
21. Lilly D., Stillwell R. Probiotics: growth-promoting factors produced by microorganisms. Science. 1965; 147 (3659): 747–8. DOI: https://doi.org/10.1126/science.147.3659.747
22. Hill C., Guarner F., Reid G., Gibson G.R., Merenstein D.J., Pot B., et al. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014; 11 (8): 506–14. DOI: https://doi.org/10.1038/nrgastro.2014.66
23. Plotnikova E.Yu., Zakharova Yu.V. The place of probiotics in modern clinical practice. Pediatriya. Prilozhenie k zhurnalu «Consilium Medicum» [Pediatrics. Supplement to the Journal «Consilium Medicum»]. 2018: (1): 95–9. DOI: https://doi.org/10.26442/2413-8460_2018.1.95-99 (in Russian)
25. Goodman C., Keating G., Georgousopoulou E., Hespe C., Levett K. Probiotics for the prevention of antibiotic-associated diarrhoea: a systematic review and meta-analysis. BMJ Open. 2021; 11 (8): e043054. DOI: https://doi.org/10.1136/bmjopen-2020-043054
26. Fan Y., Pedersen O. Gutmicrobiota in human metabolic health and disease. Nat Rev Microbiol. 2021; 19: 55–71. DOI: https://doi.org/10.1038/s41579-020-0433-9
27. Sender R., Fuchs S., Milo R. Revised estimates for the number of human and bacteria cells in the body. PLoS Biol. 2016; 14 (8): е1002533. DOI: https://doi.org/10.1371/journal.pbio.1002533
28. Integrative HMP (iHMP) Research Network Consortium. The Integrative Human Microbiome Project. Nature. 2019; 569 (7758): 641–8. DOI: https://doi.org/10.1038/s41586-019-1238-8
29. Xiao Y., Zhai Q., Zhang H., Chen W., Hill C. Gut colonization mechanisms of lactobacillus and bifidobacterium: an argument for personalized designs. Annu Rev Food Sci Technol. 2021; 12 (1): 213–33. DOI: https://doi.org/10.1146/annurev-food-061120-014739
30. 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. Rossiyskiy zhurnal gastroenterologii, gepatologii, koloproktologii [Russian Journal of Gastroenterology, Hepatology, Coloproctology]. 2021; 31 (5): 74–95. DOI: https://doi.org/10.22416/1382-4376-2021-31-5-74-95 (in Russian)
31. Korneeva O.N., Ivashkin V.T. Antibiotic-associated colitis: pathomorphology, clinic, treatment. Rossiyskiy zhurnal gastroenterologii, gepatologii, koloproktologii [Russian Journal of Gastroenterology, Hepatology, Coloproctology]. 2007; 17 (3): 65–70. (in Russian)
32. Ivashkin V.T., Yushchuk N.D., Maev I.V., Lapina T.L., Poluektova Y.A., Shifrin O.S., et al. Diagnostics and treatment of Clostridium difficile-associated disease: Guidelines of the Russian gastroenterological association. Rossiyskiy zhurnal gastroenterologii, gepatologii, koloproktologii [Russian Journal of Gastroenterology, Hepatology, Coloproctology]. 2016; 26 (5): 56–65. DOI: https://doi.org/10.22416/1382-4376-2016-26-5-56-65 (in Russian)
33. Novik A.A., Ionova T.I. Guidelines for the study of quality of life in medicine. 2nd ed. Edited by Yu.L. Shevchenko. Moscow: OLMA Media Grupp, 2007: 320 p. (in Russian) ISBN 978-5-373-01011-5.
34. Staudacher H.M., Scholz M., Lomer M.C.E., Ralph F.S., Irving P.M., Lindsay J.O., et al. Gut microbiota associations with diet in irritable bowel syndrome and the effect of low FODMAP diet and probiotics. Clin Nutr. 2021; 40 (4): 1861–70. DOI: https://doi.org/10.1016/j.clnu.2020.10.013
35. Wieërs G., Verbelen V., Van Den Driessche M., Melnik E., Vanheule G., Marot J.-C., et al. Do probiotics during in-hospital antibiotic treatment prevent colonization of gut microbiota with multi-drug-resistant bacteria? A randomized placebo-controlled trial comparing saccharomyces to a mixture of lactobacillus, bifidobacterium, and saccharomyces. Front Public Health. 2021; 8: 578089. DOI: https://doi.org/10.3389/fpubh.2020.578089
36. Ivashkin V.T., Maev I.V., Abdulganieva D.I., Alekseenko S.A., Gorelov A.V., Zakharova I.N., et al. Practical 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. Rossiyskiy zhurnal gastroenterologii, gepatologii, koloproktologii [Russian Journal of Gastroenterology, Hepatology, Coloproctology]. 2021; 31 (2): 65–91. DOI: https://doi.org/10.22416/1382-4376-2021-31-2-65-91
37. Pupa P., Apiwatsiri P., Sirichokchatchawan W., Pirarat N., Muangsin N., Shah A.A., et al. The efficacy of three double-microencapsulation methods for preservation of probiotic bacteria. Sci Rep. 2021; 11 (1): 13753. DOI: https://doi.org/10.1038/s41598-021-93263-z
38. Yeun Y., Lee J. Effect of a double-coated probiotic formulation on functional constipation in the elderly: a randomized, double blind, controlled study. Arch Pharm Res. 2014; 38 (7): 1345–50. DOI: https://doi.org/10.1007/s12272-014-0522-2
39. Han K., Wang J., Seo J.G., Kim H. Efficacy of double-coated probiotics for irritable bowel syndrome: a randomized double-blind controlled trial. J Gastroenterol. 2017; 52 (4): 432–43. DOI: https://doi.org/10.1007/s00535-016-1224-y
40. Collado M.C., Gueimonde M., Sanz Y., Salminen S. Adhesion Properties and competitive pathogen exclusion ability of Bifidobacteria with acquired acid resistance. J Food Prot. 2006; 69: 1675–9. DOI: https://doi.org/10.4315/0362-028x-69.7.1675
41. Vieira A.T., Teixeira M.M., Martins F.D.S. The role of probiotics and prebiotics in inducing gut immunity. Front Immunol. 2013; 4: 445. DOI: https://doi.org/10.3389%2Ffimmu.2013.00445
42. Bonfrate L., Di Palo D.M., Celano G., Albert A., Vitellio P., De Angelis M., et al. Effects of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 in IBS patients. Eur J Clin Invest. 2020; 50 (3): e13201. DOI: https://doi.org/10.1111/eci.13201
43. Yuan F., Ni H., Asche C.V., Kim M., Walayat S., Ren J. Efficacy of Bifidobacterium infantis 35 624 in patients with irritable bowel syndrome: a meta-analysis. Curr Med Res Opin. 2017; 33 (7): 1191–7. DOI: https://doi.org/10.1080/03007995.2017.1292230
44. Kopacz K., Phadtare S. Probiotics for the prevention of antibiotic-associated diarrhea. Healthcare. 2022; 10 (8): 1450. DOI: https://doi.org/10.3390/healthcare10081450
45. Ford A.C., Quigley E.M.M., Lacy B.E., Lembo A.J., Saito Y.A., Schiller L.R., et al. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol. 2014; 109 (10): 1547–61. DOI: https://doi.org/10.1038/ajg.2014.202
46. Tiequn B., Guanqun C., Shuo Z. Therapeutic effects of Lactobacillus in treating irritable bowel syndrome: a meta-analysis. Intern Med. 2015; 54 (3): 243–9. DOI: https://doi.org/10.2169/internalmedicine.54.2710
47. Skokovic-Sunjic D. Clinical guide to Probiotic Supplements Available in Canada. Indications, Dosage Forms, and Clinical Evidence to Date. 2015.
48. Clinical guidelines. Irritable bowel syndrome. 2021-2022-2023 (06/25/2021). Approved by the Ministry of Health of the Russian Federation. (in Russian)