Comparison of safety, effectiveness and serum inflammatory factor indexes of Saccharomyces boulardii versus Bifidobacterium triple viable in treating children with chronic diarrhea: a randomized trial

BACKGROUND: Diarrhea is common in children under 5 years of age and is an important public health problem in China. CD is the main obstacle to the growth and development of children, which brings a great burden to individuals, families and society. The objective of this work is to study the efficacy and safety of Saccharomyces boulardii versus Bifidobacterium triple viable in the treatment of CD in children. METHODS: From October 2018 to October 2020, a total of 161 children aged 2–8 years hospitalized with CD were randomly allocated into S. boulardii group, Bifidobacterium triple viable group and control group. After 14 days of treatment, the curative effect and recovery time of the three groups were evaluated. The levels of serum interleukin (IL)-6, IL-7 and tumor necrosis factor-alpha (TNF-α) before and after the treatment were valuated and compared among the three groups, together with clinical efficacy and safety. RESULTS: The recovery time of the Bifidobacterium triple viable group was significantly shorter than that of S. boulardii group (P<0.05). The marked effective rate and total effective rate of the Bifidobacterium triple viable group were significantly higher than those of the control group (P<0.05); the total effective rate of the S. boulardii group was significantly higher than that of the control group (P<0.05). The improvement in the levels of IL-6, IL-7 and TNF-α in the Bifidobacterium triple viable group was greater than that in the control group; the improvement in IL-6 and IL-7 levels in the Bifidobacterium triple viable group was greater than that in the S. boulardii group; the improvement in IL-6 and IL-7 levels in the S. boulardii group was greater than that in the control group, and the differences were statistically significant (P<0.05) CONCLUSIONS: The efficacy of Bifidobacterium triple viable and S. boulardii in the treatment of children with CD was better than that of conventional treatment. The treatment effect for Bifidobacterium triple viable was more significant, and it was proved to be safe, to shorten the course of disease, and have clinical relevance. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100046444.