Shah Jamal, Adnan Samran Hasan, Yousaf Mian Shah, Din Syed Jamal Ud, Haq Moeen Ul, Siddiqui Nadia, Shahid Minahil, Elhamid Ahmed Samir Abdul, Rauf Shiza, Afnan Muhammad
General Internal Medicine, Khyber Teaching Hospital, Peshawar, PAK.
Medicine, Dow International Medical College, Karachi, PAK.
Cureus. 2024 Oct 5;16(10):e70881. doi: 10.7759/cureus.70881. eCollection 2024 Oct.
Antibiotic-associated diarrhea (AAD) is a prevalent complication of antibiotic therapy, attributed to disruptions in gut microbiota. Probiotics are increasingly studied for their potential in preventing AAD by restoring microbial balance.
The aim of this investigation was to assess the efficacy of probiotics in reducing AAD in adult patients when compared to a placebo.
This research was conducted from March 2023 to March 2024 using a randomized, placebo-controlled design at multiple institutions: Khyber Teaching Hospital, Peshawar; Prime Teaching Hospital, Peshawar; Mufti Mahmood Memorial Teaching Hospital, Dera Ismail Khan; Shalamar Hospital, Lahore; University Hospitals of Leicester; and DHQ Teaching Hospital Kohat, enrolling 340 adult patients prescribed systemic antibiotics. Eligible participants were aged 18 years and older, while those with chronic diarrhea, inflammatory bowel disease, immunodeficiency, recent probiotic or antibiotic use, or inability to provide informed consent were excluded. The sample size was calculated using WHO guidelines, resulting in a target of 340 to ensure adequate power. Participants were randomized to receive either probiotics (Lactobacillus rhamnosus GG and Bifidobacterium longum BB536) or placebo, administered within 24 hours of starting antibiotics. Daily monitoring of bowel habits and symptoms was performed using standardized diaries, and adherence was evaluated through pill counts. Statistical analyses were performed using IBM SPSS Statistics for Windows, Version 27 (Released 2020; IBM Corp., Armonk, New York, United States), comparing the incidence, severity, and duration of AAD between groups, with a significance threshold of p < 0.05.
In the probiotic group, 31 patients (18.23%) developed AAD compared to 53 patients (31.17%) in the placebo group (p=0.01). Among those with AAD, the probiotic group experienced a shorter duration (mean 3.5 ± 1.2 days) compared to placebo (mean 5.1 ± 1.8 days, p=0.002). Adherence rates were high in both groups (probiotic: 96.4%, placebo: 95.9%). Significant improvements in bowel habits were reported more frequently in the probiotic group (77.06%) than placebo (50.59%, p=0.02). The hospital stay duration was similar between groups (probiotic: mean 7.8 ± 2.1 days, placebo: mean 8.3 ± 2.4 days, p=0.15).
Probiotics significantly reduced the incidence and duration of AAD compared to placebo, with high adherence and favorable patient-reported outcomes.
抗生素相关性腹泻（AAD）是抗生素治疗中常见的并发症，归因于肠道微生物群的破坏。益生菌因其通过恢复微生物平衡预防AAD的潜力而受到越来越多的研究。
本研究的目的是评估与安慰剂相比，益生菌在降低成年患者AAD发生率方面的疗效。
本研究于2023年3月至2024年3月在多个机构采用随机、安慰剂对照设计进行：白沙瓦开伯尔教学医院；白沙瓦总理教学医院；德拉伊斯梅尔汗穆夫提·马哈茂德纪念教学医院；拉合尔沙勒马医院；莱斯特大学医院；以及科哈特DHQ教学医院，招募了340名接受全身抗生素治疗的成年患者。符合条件的参与者年龄在18岁及以上，而患有慢性腹泻、炎症性肠病、免疫缺陷、近期使用过益生菌或抗生素、或无法提供知情同意书的患者被排除。样本量根据世界卫生组织的指南计算，目标为340例以确保足够效能。参与者被随机分配接受益生菌（鼠李糖乳杆菌GG和长双歧杆菌BB536）或安慰剂，在开始使用抗生素后24小时内给药。使用标准化日记每日监测排便习惯和症状，并通过清点药丸评估依从性。使用IBM SPSS Statistics for Windows，Version 27（2020年发布；IBM公司，美国纽约州阿蒙克）进行统计分析，比较两组之间AAD的发生率、严重程度和持续时间，显著性阈值为p<0.05。
益生菌组有31例患者（18.23%）发生AAD，而安慰剂组有53例患者（31.17%）发生AAD（p=0.01）。在发生AAD的患者中，益生菌组的持续时间较短（平均3.5±1.2天），而安慰剂组为（平均5.1±1.8天，p=0.002）。两组的依从率都很高（益生菌组：96.4%，安慰剂组：95.9%）。益生菌组报告排便习惯有显著改善的频率（77.06%）高于安慰剂组（50.59%，p=0.02）。两组的住院时间相似（益生菌组：平均7.8±2.1天，安慰剂组：平均8.3±2.4天，p=0.15）。
与安慰剂相比，益生菌显著降低了AAD的发生率和持续时间，依从性高且患者报告的结果良好。
