Randomised clinical trial: efficacy and safety of H. pylori eradication treatment with and without Saccharomyces boulardii supplementation.
Eur J Cancer Prev
; 33(3): 217-222, 2024 May 01.
Article
in En
| MEDLINE
| ID: mdl-37942999
ABSTRACT
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 500â mg, amoxicillin 1000â mg, esomeprazole 40â mg) twice daily. Randomization was applied based on two factors 1)addition of Saccharomyces boulardii CNCM I-745 500â 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 â =â 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 â =â 0.183). S. boulardii reduced the frequency of adverse events ( P â =â 0.033) in 14-day regimen, particularly treatment-associated diarrhea ( P â =â 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Helicobacter Infections
/
Saccharomyces boulardii
Limits:
Adult
/
Humans
/
Middle aged
Language:
En
Journal:
Eur J Cancer Prev
Journal subject:
NEOPLASIAS
/
SAUDE PUBLICA
Year:
2024
Document type:
Article