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三种双歧杆菌混合物可减轻肠易激综合征患儿的腹痛并改善生活质量:一项多中心、随机、双盲、安慰剂对照、交叉试验。

A Mixture of 3 Bifidobacteria Decreases Abdominal Pain and Improves the Quality of Life in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.

作者信息

Giannetti Eleonora, Maglione Marco, Alessandrella Annalisa, Strisciuglio Caterina, De Giovanni Donatella, Campanozzi Angelo, Miele Erasmo, Staiano Annamaria

机构信息

*Department of Translational Medical Sciences, Section of Pediatrics, Federico II University †Department of Woman, Child, and General and Specialistic Surgery, Second University of Naples, Naples ‡Department of Pediatrics, University of Foggia, Foggia, Italy.

出版信息

J Clin Gastroenterol. 2017 Jan;51(1):e5-e10. doi: 10.1097/MCG.0000000000000528.

DOI:10.1097/MCG.0000000000000528
PMID:27306945
Abstract

GOALS

We assessed the efficacy of a probiotic mixture of Bifidobacterium infantis M-63, breve M-16V, and longum BB536 in improving abdominal pain (AP) and quality of life (QoL) in children with irritable bowel syndrome (IBS) and functional dyspepsia (FD).

BACKGROUND

AP-associated functional gastrointestinal disorders, particularly IBS and FD, are common in pediatrics, and no well-established treatment is currently available. Although probiotics have shown promising results in adults, data in children are heterogeneous.

STUDY

Forty-eight children with IBS (median age, 11.2 y; range, 8 to 17.9 y) and 25 with FD (age, 11.6 y; range, 8 to 16.6 y) were randomized to receive either a mixture of 3 Bifidobacteria or a placebo for 6 weeks. After a 2-week "washout" period, each patient was switched to the other group and followed up for further 6 weeks. At baseline and follow-up, patients completed a symptom diary and a QoL questionnaire. AP resolution represented the primary outcome parameter.

RESULTS

In IBS, but not in FD, Bifidobacteria determined a complete resolution of AP in a significantly higher proportion of children, when compared with placebo (P=0.006), and significantly improved AP frequency (P=0.02). The proportion of IBS children with an improvement in QoL was significantly higher after probiotics than after placebo (48% vs. 17%, P=0.001), but this finding was not confirmed in FD.

CONCLUSIONS

In children with IBS a mixture of Bifidobacterium infantis M-63, breve M-16V, and longum BB536 is associated with improvement in AP and QoL. These findings were not confirmed in FD subjects. Trial identifier: NCT02566876 (http://www.clinicaltrial.gov).

摘要

目标

我们评估了婴儿双歧杆菌M-63、短双歧杆菌M-16V和长双歧杆菌BB536的益生菌混合物对改善肠易激综合征(IBS)和功能性消化不良(FD)患儿腹痛(AP)及生活质量(QoL)的疗效。

背景

与AP相关的功能性胃肠疾病,尤其是IBS和FD,在儿科中很常见,目前尚无成熟的治疗方法。尽管益生菌在成人中已显示出有前景的结果,但儿童的数据参差不齐。

研究

48例IBS患儿(中位年龄11.2岁;范围8至17.9岁)和25例FD患儿(年龄11.6岁;范围8至16.6岁)被随机分为接受3种双歧杆菌混合物或安慰剂治疗6周。经过2周的“洗脱”期后,每位患者换至另一组并继续随访6周。在基线和随访时,患者完成症状日记和QoL问卷。AP缓解是主要结局参数。

结果

在IBS患儿中,与安慰剂相比,双歧杆菌使更高比例的儿童AP完全缓解(P = 0.006),且显著改善了AP发作频率(P = 0.02),而在FD患儿中未出现此情况。益生菌治疗后IBS患儿QoL改善的比例显著高于安慰剂组(48%对17%,P = 0.001),但在FD患儿中未得到证实。

结论

在IBS患儿中,婴儿双歧杆菌M-63、短双歧杆菌M-16V和长双歧杆菌BB536的混合物与AP改善及QoL提高相关。在FD患儿中未证实这些结果。试验标识符:NCT02566876(http://www.clinicaltrial.gov)

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