Chung Allison, Sehgal Mukul, Gavrilita Cristina, Falkos Sheryl, Vidal Rosa
Department of Pharmacy Practice (AMC), Auburn University Harrison College of Pharmacy, Mobile, AL.
Departments of Pediatrics (AMC, CG, MS, SF), University of South Alabama, School of Medicine, Mobile, AL.
J Pediatr Pharmacol Ther. 2025 Feb;30(1):47-51. doi: 10.5863/1551-6776-30.1.47. Epub 2025 Feb 10.
The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the pediatric intensive care unit (PICU).
This was a prospective randomized, double-blind, placebo-controlled pilot trial in an academic PICU over 1 year. Patients ≤ 17 years who required antibiotic therapy ≥ 72 hours were randomly assigned to receive placebo or LGG. Exclusion criteria included antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and gastrointestinal (GI) disorders. LGG (30 × 10 colony forming units) or a matching placebo capsule was administered twice daily for the duration of antibiotic therapy. Diarrhea was defined as 3 or more loose stools in 24 hours.
A total of 36 patients were enrolled with 19 patients eligible for final analysis; 10 in the LGG group and 9 in the placebo group. Median age and weight of LGG vs placebo groups were 0.4 (0.17-1.42) vs 0.86 (1.21-10.92) years, p = 0.48, and 6 (3.4-9.9) vs 9.8 (3.71-39.6) kg, p = 0.31, respectively. Antibiotic associated diarrhea was experienced in 30% vs 55.5% of patients in the LGG groups vs placebo (p = 0.375), respectively. The median PICU length of stay for the patients with AAD was 6 days compared with 7.5 days in placebo group (p = 0.033). The RR ratio for AAD when using LGG was 0.59 (95% CI, 0.21-1.6). No adverse events were reported or attributed to LGG.
Results of this pilot study indicate that LGG is safe and could potentially reduce the incidence of AAD in the critically ill pediatric patients at this academic institution. Our findings suggest clinicians should consider the use of LGG in appropriate PICU patients.
本研究的目的是评估鼠李糖乳杆菌GG(LGG)预防儿科重症监护病房(PICU)中抗生素相关性腹泻(AAD)的疗效。
这是一项在一所学术性PICU中进行的为期1年的前瞻性随机、双盲、安慰剂对照试验。年龄≤17岁且需要抗生素治疗≥72小时的患者被随机分配接受安慰剂或LGG。排除标准包括在研究前48小时内使用过抗生素、先前使用过益生菌、既往有腹泻、使用泻药治疗、免疫功能低下以及胃肠道(GI)疾病。在抗生素治疗期间,每天两次给予LGG(30×10菌落形成单位)或匹配的安慰剂胶囊。腹泻定义为24小时内有3次或更多次稀便。
共纳入36例患者,其中19例符合最终分析条件;LGG组10例,安慰剂组9例。LGG组与安慰剂组的中位年龄分别为0.4(0.17 - 1.42)岁和0.86(1.21 - 10.92)岁,p = 0.48;中位体重分别为6(3.4 - 9.9)kg和9.8(3.71 - 39.6)kg,p = 0.31。LGG组和安慰剂组患者发生抗生素相关性腹泻的比例分别为30%和55.5%(p = 0.375)。发生AAD患者在PICU的中位住院时间为6天,而安慰剂组为7.5天(p = 0.033)。使用LGG时AAD的RR比为0.59(95%CI,0.21 - 1.6)。未报告与LGG相关的不良事件。
这项初步研究的结果表明,LGG是安全的,并且可能降低该学术机构中危重症儿科患者AAD的发生率。我们的研究结果提示临床医生应考虑在合适的PICU患者中使用LGG。