Randomised clinical trial: efficacy and safety of H. pylori eradication treatment with and without Saccharomyces boulardii supplementation.

2023-11-06
European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP) 33(3)
- Olga Sjomina
- Inese Poļaka
- Jekaterina Suhorukova
- Reinis Vangravs
- Sergejs Paršutins
- Viktoria Knaze
- Jin Young Park
- Rolando Herrero
- Raul Murillo
- Mārcis Leja

PubMed: 37942999
DOI: 10.1097/cej.0000000000000858

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 404
Population: healthy individuals aged 40-64 years
Methods: randomized clinical trial; clarithromycin-containing triple therapy with or without Saccharomyces boulardii CNCM I-745 500 mg BID; treatment duration 10 or 14 days
Blinding: Open-label
Duration: 10 or 14 days

Large Human Trial

Background

Standard triple therapy is commonly prescribed Helicobacter pylori eradication regimen in Europe. However, the world is witnessing declines in eradication success. It is crucial to find better treatment options.

Aims

To evaluate efficacy, compliance and side effects of H. pylori eradication treatment by adding Saccharomyces boulardii .

Methods

We conducted a randomized clinical trial within the GISTAR cohort, consisting of healthy individuals aged 40-64 years. Participants were administered clarithromycin-containing triple therapy (clarithromycin 500 mg, amoxicillin 1000 mg, esomeprazole 40 mg) twice daily. Randomization was applied based on two factors: 1)addition of Saccharomyces boulardii CNCM I-745 500 mg BID or not; 2)treatment duration of 10 or 14 days. Treatment completion and adverse events were assessed via telephone interview 21-28 days after medication delivery. The efficacy was evaluated using a 13C-urea breath test (UBT) six months after treatment.

Results

Altogether 404 participants were enrolled; data on adverse events were available from 391. Overall, 286 participants received follow-up UBT. Intention-to-treat analysis revealed higher eradication rates for 10-day probiotic treatment (70.8% vs. 54.6%, P = 0.022), but not for 14-day. Probiotic subgroups combined showed non-significantly higher efficacy in per-protocol analysis (90.6% vs. 85.0%, P = 0.183). S. boulardii reduced the frequency of adverse events ( P = 0.033) in 14-day regimen, particularly treatment-associated diarrhea ( P = 0.032). However, after the adjustment to control Type I error, results lost their significance.

Conclusion

Addition of S. boulardii to 14-day clarithromycin-containing triple regimen non-significantly lowers the likelihood of diarrhea and does not increase the eradication rate.

Research Insights

Saccharomyces boulardii→Increased Helicobacter pylori Eradication Rate
Intention-to-treat analysis revealed higher eradication rates for 10-day probiotic treatment (70.8% vs. 54.6%, P = 0.022), but not for 14-day. Probiotic subgroups combined showed non-significantly higher efficacy in per-protocol analysis (90.6% vs. 85.0%, P = 0.183).
Effect
Neutral
Effect size
Small
Dose
500 mg BID
Saccharomyces boulardii→Reduced Diarrhea
S. boulardii reduced the frequency of adverse events (P = 0.033) in 14-day regimen, particularly treatment-associated diarrhea (P = 0.032). However, after the adjustment to control Type I error, results lost their significance.
Effect
Neutral
Effect size
Small
Dose
500 mg BID

Adverse Events Reported

Saccharomyces boulardii→adverse events (overall)
S. boulardii reduced the frequency of adverse events ( P = 0.033) in 14-day regimen, particularly treatment-associated diarrhea ( P = 0.032). However, after the adjustment to control Type I error, results lost their significance.
Finding
No significant difference
Significant
No
Saccharomyces boulardii→diarrhea
S. boulardii reduced the frequency of adverse events ( P = 0.033) in 14-day regimen, particularly treatment-associated diarrhea ( P = 0.032). However, after the adjustment to control Type I error, results lost their significance.
Finding
No significant difference
Significant
No