Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial.

IF 3 3区医学 Q1 PEDIATRICS

European Journal of Pediatrics Pub Date : 2024-12-01 Epub Date: 2024-10-11 DOI:10.1007/s00431-024-05806-x

J M Moreno-Villares, D Andrade-Platas, M Soria-López, G Colomé-Rivero, A Catalan Lamban, M G Martinez-Figueroa, J Espadaler-Mazo, J Valverde-Molina

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引用次数: 0

Abstract

We aimed to compare the efficacy of Bifidobacterium longum KABP042 + Pediococcus pentosaceus KABP041 (BL + PP) vs. Limosilactobacillus reuteri DSM17938 (LR) in alleviating the symptoms of infant colic, as commercially available formulations. A randomized, multicenter, parallel, single-blind (investigator) trial was conducted in 112 colicky infants diagnosed as per Rome IV criteria and randomly allocated to receive BL + PP orally (10⁹ colony-forming units [CFU]/day, n = 55) or LR (10⁸ CFU/day, n = 57) for 21 days. Primary study outcomes were percentage of responders (≥ 50% reduction in crying and fussing time from baseline, as reported by parents in a structured diary) and daily crying and fussing time (minutes/day) on days 7, 14, and 21 after randomization. Study groups were comparable at baseline. Responder rate was significantly higher in BP + PP group vs. LR group at days 7 (61.1% vs. 37.5%, p = 0.013) and 14 (84.6% vs. 59.3%, p = 0.004). Crying and fussing time (median [IQR]) became significantly lower in BL + PP group vs. LR group on day 7 (119 [60-210] vs. 180 [110-270]; p = 0.028), day 14 (60.0 [30-105] vs. 120 [60-180]; p = 0.017), and day 21 (29 [0-85] vs. 67 [30-165]; p = 0.011). No significant differences were found in the number of adverse events between the groups.

Conclusion: The specific formulation of B. longum KABP042 and P. pentosaceus KABP041 achieved a higher response rate and a larger reduction in crying and fussing time in colicky infants. Both probiotic interventions were well tolerated.

Trial registration: The study was retrospectively registered as NCT05271747 on February 28th, 2022.

What is known: • L. reuteri DSM17938 (LR) is the most researched probiotic strain for infant colic against placebo in randomized, controlled clinical trials, and is recommended in various guidelines. A novel probiotic combining strains B. longum KABP042 and P. pentosaceus KABP041 (BL + PP) has also demonstrated efficacy in infant colic against placebo.

What is new: • This randomized study provides the first direct comparison of two probiotics for infant colic. BL + PP seems to be superior to LR in reducing crying time.

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益生菌混合物长双歧杆菌 KABP042 加五味子球菌 KABP041 与柠檬酸乳杆菌 DSM17938 在治疗婴儿肠绞痛方面的疗效比较：随机临床试验。

我们的目的是比较长双歧杆菌 KABP042 + 五胜肽木薯球菌 KABP041（BL + PP）与沙门氏菌 DSM17938（LR）这两种市售制剂在缓解婴儿肠绞痛症状方面的功效。一项随机、多中心、平行、单盲（研究者）试验在 112 名按照罗马 IV 标准诊断为肠绞痛的婴儿中进行，并随机分配他们口服 BL + PP（109 菌落总数单位 [CFU]/天，n = 55）或 LR（108 菌落总数单位/天，n = 57）21 天。主要研究结果为应答者百分比（哭闹时间比基线减少≥50%，由家长在结构化日记中报告）以及随机分配后第 7、14 和 21 天的每日哭闹时间（分钟/天）。各研究组的基线值相当。在第 7 天（61.1% 对 37.5%，p = 0.013）和第 14 天（84.6% 对 59.3%，p = 0.004），BP + PP 组的应答率明显高于 LR 组。在第 7 天（119 [60-210] vs. 180 [110-270]；p = 0.028）、第 14 天（60.0 [30-105] vs. 120 [60-180]；p = 0.017）和第 21 天（29 [0-85] vs. 67 [30-165]；p = 0.011），BL + PP 组的哭闹时间（中位数 [IQR] ）明显低于 LR 组。两组的不良反应数量无明显差异：结论：B. longum KABP042 和 P. pentosaceus KABP041 的特定配方对肠绞痛婴儿的反应率更高，哭闹时间减少更多。两种益生菌干预措施的耐受性都很好：该研究于2022年2月28日回顾性注册为NCT05271747：- 在随机对照临床试验中，L. reuteri DSM17938（LR）是针对婴儿肠绞痛与安慰剂对比研究最多的益生菌菌株，也是各种指南推荐的益生菌菌株。一种新型益生菌结合了 B. longum KABP042 菌株和 P. pentosaceus KABP041 菌株（BL + PP），对婴儿肠绞痛的疗效也优于安慰剂：- 这项随机研究首次对两种治疗婴儿肠绞痛的益生菌进行了直接比较。在减少哭闹时间方面，BL + PP 似乎优于 LR。

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来源期刊

European Journal of Pediatrics 医学-小儿科

CiteScore

5.90

自引率

2.80%

发文量

367

审稿时长

3-6 weeks

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