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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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

期刊介绍： The European Journal of Pediatrics (EJPE) is a leading peer-reviewed medical journal which covers the entire field of pediatrics. The editors encourage authors to submit original articles, reviews, short communications, and correspondence on all relevant themes and topics. EJPE is particularly committed to the publication of articles on important new clinical research that will have an immediate impact on clinical pediatric practice. The editorial office very much welcomes ideas for publications, whether individual articles or article series, that fit this goal and is always willing to address inquiries from authors regarding potential submissions. Invited review articles on clinical pediatrics that provide comprehensive coverage of a subject of importance are also regularly commissioned. The short publication time reflects both the commitment of the editors and publishers and their passion for new developments in the field of pediatrics. EJPE is active on social media (@EurJPediatrics) and we invite you to participate. EJPE is the official journal of the European Academy of Paediatrics (EAP) and publishes guidelines and statements in cooperation with the EAP.