Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis.

BACKGROUND: The choice of an appropriate probiotic for pediatric acute gastroenteritis (PAGE) can be confusing. Our aim was to compare the efficacy and safety of 2 probiotics (Saccharomyces boulardii CNCM I-745 vs a 4-strain mixture of Bacillus clausii O/C, SIN, N/R, T) for the treatment of PAGE. METHODS: A 2-arm parallel, randomized trial recruited children (6 months to 5 years old) with mild-moderate acute diarrhea, from 8 centers in Argentina. A total of 317 children were enrolled and blindly randomized to 5 days of either S boulardii CNCM I-745 (n = 159) or a 4-strain mixture of B clausii (n = 158), then followed for 7 days post-probiotic treatment. A stool sample was collected at inclusion for pathogen identification. The primary outcome was duration of diarrhea defined as the time from enrollment to the last loose stool followed by the first 24-hour period with stool consistency improvement. Secondary outcomes included frequency of loose stools/day, severity of diarrhea, number reporting no diarrhea at Day 6, time-to-first formed stool, recurrence of diarrhea by study end (Day 12) and safety outcomes. RESULTS: Three hundred twelve (98%) children completed the study. S boulardii CNCM I-745 showed a significant reduction (P = .04) in the mean duration of diarrhea (64.6 hours, 95% confidence interval [CI] 56.5-72.8) compared to those given B clausii (78.0 hours, 95% CI 69.9-86.1). Both probiotics showed improvement in secondary outcomes and were well-tolerated. CONCLUSION: In this study, S boulardii CNCM I-745 demonstrated better efficacy than B clausii mix for reducing the duration of pediatric acute diarrhea.

Application of Chitosan and Chondroitin Sulphate Aerogels in a Patient With Diabetes With an Open Forefoot Transmetatarsal Amputation.

INTRODUCTION: Diabetic foot ulcers may lead to nontraumatic amputations of the foot, leading to a decrease in patient quality of life. Transmetatarsal amputations (TMAs) represent an effective surgical procedure in cases of severe foot infection, but the tissue reconstruction is complicated and additional procedures should be considered. The present case report evaluates the wound closure of an open TMA in a patient with diabetes treated with a new aerogel composed of chitosan (ChS) and chondroitin sulphate (CS), without needing a skin graft. CASE REPORT: A 72-year-old man with diabetes and a history of successive amputations was admitted to a hospital in Valdivia, Chile, due to a severe infection of toes 2 and 4 of the right foot. After the diagnosis of gangrene and osteomyelitis, the patient underwent a TMA of his right forefoot. The surgeon proposed the incorporation of ChS and CS aerogels to accelerate wound healing to avoid another surgical procedure. The TMA surgical wound area closed 50% after day 28 from starting treatment with aerogels. Complete closure was achieved at day 94 of treatment with aerogels, with good epithelial tissue and favorable cosmetic results and without residual limb deformities. The patient experienced minimal physical and psychological impairment from the procedure. Other surgical procedures were not necessary. CONCLUSIONS: Due to the results of this patient, use of ChS and CS aerogels could represent an alternative treatment for forefoot TMA wound closure and prevent further surgical procedures, such as skin grafting. Future works should consider a larger number of cases.