Combined With Quadruple Therapy for Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial.

Whether probiotics helped the () eradication was still highly controversial. The non-bacterial () has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of combined with quadruple therapy for eradication and associated side effects. Three hundred and sixty infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted C/C-urea breath tests 4 weeks after the therapy completion. and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, = 0.034) and diarrhea (11.2 vs. 21.2%, = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, = 0.426; PP: 89.7 vs. 94.2%, = 0.146). The joint use of and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449-4.338) recovery. ameliorated eradicationinduced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of on the rate of eradication. The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828.