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囊性纤维化患者中的益生菌:一项双盲交叉安慰剂对照研究:欧洲儿科胃肠病、肝病和营养学会胰腺/囊性纤维化工作组的初步研究

Probiotics in cystic fibrosis patients: A double blind crossover placebo controlled study: Pilot study from the ESPGHAN Working Group on Pancreas/CF.

作者信息

Van Biervliet Stephanie, Hauser Bruno, Verhulst Stijn, Stepman Hedwig, Delanghe Joris, Warzee Jean-Pol, Pot Bruno, Vandewiele Tom, Wilschanski Michael

机构信息

Ghent University Hospital, Pediatric Gastroenterology, CF centre, Ghent, Belgium.

Vrije Universiteit Brussel, Pediatric Gastroenterology, CF Centre, Brussels, Belgium.

出版信息

Clin Nutr ESPEN. 2018 Oct;27:59-65. doi: 10.1016/j.clnesp.2018.06.008. Epub 2018 Jul 20.

DOI:10.1016/j.clnesp.2018.06.008
PMID:30144894
Abstract

BACKGROUND

A potential positive effect of probiotics in cystic fibrosis (CF) on fecal calprotectin (FCP), pulmonary exacerbations and weight has been described in small controlled trials.

METHODS

A double-blind multicenter cross-over study (2 × 4 m) was performed looking at abdominal pain, nutritional status, pulmonary function, pulmonary exacerbation, FCP and lactulose/mannitol gut permeability test. Patients kept a diary with daily scoring of abdominal pain, stool frequency and consistency as well as treatment changes.

RESULTS

31 CF patients entered the study of which 25 finished it. At start patients aged 9.3yrs (6.9-12.2), had a median BMI z-score of -0.5 (-1.5-0.08), height z-score of -0.4 (-1.1-0.05) and FEV1% of 100% (87.2-106.6). Median FCP at start was 61 μg/g (17-108) and gut permeability 0.079 (0.051-0.122). No significant changes were observed in the clinical parameters (BMI, FEV1%, abdominal pain, exacerbations). Despite being frequently abnormal (17/28 (61%) >50 mg/kg), FCP did not change significantly with probiotics. The proportion of patients with normal permeability was 8% during placebo and 32% during probiotic treatment (p = 0.031). FCP correlated to BMI z-score (p = 0.043) and gut permeability to abdominal pain (p = 0.015). The microbiome revealed a high predominance of Actinobacteria and Proteobacteriae. Probiotic supplementation did not result in a shift at the phylum nor at phylogenetic level.

CONCLUSION

Normalization of gut permeability was observed in 13% of patients during probiotic treatment. However, none of the previously described effects could be confirmed.

摘要

背景

小型对照试验已表明,益生菌对囊性纤维化(CF)患者的粪便钙卫蛋白(FCP)、肺部恶化及体重可能具有积极作用。

方法

开展了一项双盲多中心交叉研究(2×4个月),观察腹痛、营养状况、肺功能、肺部恶化情况、FCP以及乳果糖/甘露醇肠道通透性试验。患者记录日记,对腹痛、大便频率及性状以及治疗变化进行每日评分。

结果

31例CF患者进入研究,其中25例完成研究。研究开始时,患者年龄为9.3岁(6.9 - 12.2岁),BMI z评分中位数为 -0.5(-1.5 - 0.08),身高z评分为 -0.4(-1.1 - 0.05),第1秒用力呼气容积百分比(FEV1%)为100%(87.2 - 106.6)。研究开始时FCP中位数为61μg/g(17 - 108),肠道通透性为0.079(0.051 - 0.122)。临床参数(BMI、FEV1%、腹痛、病情恶化)未观察到显著变化。尽管FCP经常异常(17/28(61%)>50mg/kg),但使用益生菌后FCP无显著变化。安慰剂治疗期间肠道通透性正常的患者比例为8%,益生菌治疗期间为32%(p = 0.031)。FCP与BMI z评分相关(p = 0.043),肠道通透性与腹痛相关(p = 0.015)。微生物组显示放线菌门和变形菌门占主导地位。补充益生菌未导致门水平或系统发育水平的转变。

结论

益生菌治疗期间,13%的患者肠道通透性恢复正常。然而,之前描述的任何作用均未得到证实。

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