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《L. reuteri DSM17938 在神经性厌食症儿童和青少年营养恢复和治疗便秘中的作用:一项随机、双盲、安慰剂对照研究》

"The role of L. reuteri DSM17938 in nutritional recovery and treatment of constipation in children and adolescents with anorexia nervosa - a randomized, double blind, placebo controlled study".

机构信息

Department of Pediatric Gastroenterology, Hepatology and Nutrition, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia; University of Zagreb, School of Dental Medicine, Croatia.

Health Center Karlovac, Croatia.

出版信息

Clin Nutr ESPEN. 2021 Dec;46:47-53. doi: 10.1016/j.clnesp.2021.08.016. Epub 2021 Sep 8.

Abstract

BACKGROUND

Anorexia nervosa (AN) carries the risk of potentially irreversible medical complications, especially in children and adolescents. Constipation is frequent and difficult to manage. Due to the symptoms it causes, constipation can further compromise nutritional rehabilitation.

OBJECTIVE

To investigate the role of probiotics (Lactobacillus reuteri DSM 17938) in children and adolescent with AN.

DESIGN, SETTING AND PARTICIPANTS: Randomized, double blind, placebo controlled study in 31 female pediatric AN patients with constipation, referred to nutritional therapy in Pediatric Gastroenterology Department, Sestre milosrdnice University Hospital Centre in Zagreb.

METHODS

At hospitalization, patients were randomly assigned into two groups; one taking L. reuteri, and other placebo for 3 months, along with the conventional nutritional rehabilitation. Patients were followed 3 months after stopping the treatment. The primary outcome was relief of constipation, assessed after 3 months, while secondary outcomes were normalization of body weight, stool frequency and consistency, relief of dyspepsia, weight gain and recovery of malnutrition regarding bone density and vitamin D3 levels.

RESULTS

The study showed statistically significant difference between the two groups considering the stool frequency (6.4 vs. 4.2 stools/week; p < 0.05) and normalization of body weight (93 vs. 63%; p = 0.04) after 6 months, but no significant effect on the rate of relief of constipation (87 vs. 64%; p = 0.22) at 3 months. In the L. reuteri group, the normalization of BMD was achieved in 8/15, whereas in the placebo group, in 3/16 patients. However, there was no statistically significant difference compared to the placebo group regarding the BMD recovery as well as the normalization of D3 levels (p = 0.056).

CONCLUSIONS

Probiotics may serve as simple and safe adjuvant therapy of constipation in childhood AN and contribute to faster nutritional recovery. Although a statistically significant difference between the two group in relief of constipation could not be shown after 3 months, a benefit from probiotics could be in increasing stool frequency and nutritional recovery in childhood AN after six months. Registered under ClinicalTrials.gov Identifier no. NCT02004288.

摘要

背景

神经性厌食症(AN)存在潜在不可逆的医学并发症风险,尤其是在儿童和青少年中。便秘较为常见且难以处理。由于其引起的症状,便秘可能会进一步影响营养康复。

目的

研究益生菌(雷氏乳杆菌 DSM 17938)在患有 AN 的儿童和青少年中的作用。

设计、地点和参与者:这是一项在 31 名患有便秘的儿科 AN 女性患者中进行的随机、双盲、安慰剂对照研究,这些患者被转介到萨格勒布的斯捷斯特米尔诺塞德大学医院中心的儿科胃肠病学部门进行营养治疗。

方法

在住院时,患者被随机分为两组;一组服用 L. reuteri,另一组服用安慰剂,为期 3 个月,同时进行常规营养康复。在停止治疗后 3 个月对患者进行随访。主要结局是在 3 个月后评估便秘缓解情况,次要结局是体重正常化、粪便频率和稠度、消化不良缓解、体重增加和恢复骨密度及维生素 D3 水平的营养不良情况。

结果

研究显示,两组之间在粪便频率(6.4 次/周与 4.2 次/周;p<0.05)和体重正常化(93%与 63%;p=0.04)方面存在统计学显著差异,但在 3 个月时缓解便秘的比率(87%与 64%;p=0.22)无显著影响。在 L. reuteri 组中,15 名患者中有 8 名实现了 BMD 正常化,而在安慰剂组中,16 名患者中有 3 名。然而,与安慰剂组相比,BMD 恢复和 D3 水平正常化方面没有统计学显著差异(p=0.056)。

结论

益生菌可能是治疗儿童 AN 性便秘的简单、安全的辅助治疗方法,并有助于更快的营养恢复。尽管在 3 个月时无法显示两组之间在缓解便秘方面的统计学显著差异,但益生菌可能在 6 个月后增加粪便频率和儿童 AN 的营养恢复方面有益。在 ClinicalTrials.gov 注册号为 NCT02004288 的试验中进行了注册。

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