[Study on the efficacy of combination therapy with rifaximin and Saccharomyces boulardii CNCM I-745 in patients with small intestinal bacterial overgrowth associated with long-term use of proton pump inhibitors].
I V Maev, D N Andreev, R I Shaburov, A V Zaborovsky, A K Fomenko, P S Sokolov, S V Tsaregorodtsev, M K Devkota, D T Dicheva, S V Cheremushkin, N V Cheremushkinа, A V Vychkin
{"title":"[Study on the efficacy of combination therapy with rifaximin and <i>Saccharomyces boulardii</i> CNCM I-745 in patients with small intestinal bacterial overgrowth associated with long-term use of proton pump inhibitors].","authors":"I V Maev, D N Andreev, R I Shaburov, A V Zaborovsky, A K Fomenko, P S Sokolov, S V Tsaregorodtsev, M K Devkota, D T Dicheva, S V Cheremushkin, N V Cheremushkinа, A V Vychkin","doi":"10.26442/00403660.2025.08.203301","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the efficacy of combination therapy with rifaximin and <i>Saccharomyces boulardii</i> CNCM I-745 versus rifaximin monotherapy in patients with small intestinal bacterial overgrowth (SIBO) associated with long-term proton pump inhibitor (PPI) use.</p><p><strong>Materials and methods: </strong>A prospective comparative study with two parallel groups was conducted. Eligible patients were those on continuous long-term PPI therapy (> 3 months) with confirmed SIBO. SIBO was diagnosed in all patients using a lactulose Hydrogen/Methane Breath Test (HMBT). Symptom severity was assessed using the validated \"7 × 7\" Questionnaire, and Quality of Life (QoL) was evaluated using the SF-36 Health Status Survey. Enrolled patients were randomized into two groups based on a 7-day treatment regimen: Group 1 received rifaximin (400 mg twice daily); Group 2 received rifaximin (400 mg twice daily) plus the probiotic <i>Saccharomyces boulardii</i> CNCM I-745 (Enterol® drug product, Biocodex, France; 500 mg twice daily). SIBO eradication was confirmed via repeat lactulose HMBT, and symptom severity/QoL were reassessed 4 weeks after treatment completion.</p><p><strong>Results: </strong>108 patients were enrolled (mean age 38.7 ± 8.9 years; 65.7% female). Mean PPI treatment duration at enrollment was 4.81 months (95% confidence interval 4.15-5.46). At 4-week follow-up, repeat lactulose HMBT showed SIBO persistence in 41.5% of Group 1 (<i>n</i> = 22/53) versus 21.8% in Group 2 (<i>n</i> = 12/55; <i>p</i> = 0.038). Statistically significant resolution of diarrhea was observed only in Group 2 (<i>p = </i>0.033). The final median \"7 × 7\" Questionnaire score was significantly lower in Group 2 (<i>p</i> = 0.0010). Both groups showed significant trends toward QoL improvement on the SF-36 survey.</p><p><strong>Conclusion: </strong>This prospective comparative study demonstrates that combination therapy with rifaximin and <i>Saccharomyces boulardii</i> CNCM I-745 appears more effective than rifaximin monotherapy for SIBO eradication, symptom regression, and QoL improvement in patients with PPI-associated SIBO.</p>","PeriodicalId":22209,"journal":{"name":"Terapevticheskii Arkhiv","volume":"97 8","pages":"660-667"},"PeriodicalIF":0.3000,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Terapevticheskii Arkhiv","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.26442/00403660.2025.08.203301","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Aim: To evaluate the efficacy of combination therapy with rifaximin and Saccharomyces boulardii CNCM I-745 versus rifaximin monotherapy in patients with small intestinal bacterial overgrowth (SIBO) associated with long-term proton pump inhibitor (PPI) use.
Materials and methods: A prospective comparative study with two parallel groups was conducted. Eligible patients were those on continuous long-term PPI therapy (> 3 months) with confirmed SIBO. SIBO was diagnosed in all patients using a lactulose Hydrogen/Methane Breath Test (HMBT). Symptom severity was assessed using the validated "7 × 7" Questionnaire, and Quality of Life (QoL) was evaluated using the SF-36 Health Status Survey. Enrolled patients were randomized into two groups based on a 7-day treatment regimen: Group 1 received rifaximin (400 mg twice daily); Group 2 received rifaximin (400 mg twice daily) plus the probiotic Saccharomyces boulardii CNCM I-745 (Enterol® drug product, Biocodex, France; 500 mg twice daily). SIBO eradication was confirmed via repeat lactulose HMBT, and symptom severity/QoL were reassessed 4 weeks after treatment completion.
Results: 108 patients were enrolled (mean age 38.7 ± 8.9 years; 65.7% female). Mean PPI treatment duration at enrollment was 4.81 months (95% confidence interval 4.15-5.46). At 4-week follow-up, repeat lactulose HMBT showed SIBO persistence in 41.5% of Group 1 (n = 22/53) versus 21.8% in Group 2 (n = 12/55; p = 0.038). Statistically significant resolution of diarrhea was observed only in Group 2 (p = 0.033). The final median "7 × 7" Questionnaire score was significantly lower in Group 2 (p = 0.0010). Both groups showed significant trends toward QoL improvement on the SF-36 survey.
Conclusion: This prospective comparative study demonstrates that combination therapy with rifaximin and Saccharomyces boulardii CNCM I-745 appears more effective than rifaximin monotherapy for SIBO eradication, symptom regression, and QoL improvement in patients with PPI-associated SIBO.
期刊介绍：
Терапевтический архив
The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal.
Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases.
The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists.
The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal.
The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory.
The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations.
By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE).
The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
