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[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].

  • 2025-08-28
  • Terapevticheskii arkhiv 97(8)
    • 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

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 108
Population
108 patients with SIBO associated with long-term PPI use (mean age 38.7 ± 8.9 years; 65.7% female)
Methods
Prospective comparative study with two parallel groups; randomization into 7-day treatment with rifaximin monotherapy (400 mg twice daily) or rifaximin plus Saccharomyces boulardii CNCM I-745 (500 mg twice daily); SIBO diagnosis and eradication confirmed via lactulose Hydrogen/Methane Breath Test; symptom severity assessed by '7 × 7' Questionnaire and QoL by SF-36
Blinding
Open-label
Duration
7-day treatment with 4-week follow-up
Funding
Unclear
  • Large Human Trial

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.

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