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慢性功能性便秘患者补充益生菌、益生元及合生元的随机双盲安慰剂对照临床试验

Supplementation with probiotics, prebiotics, and synbiotics in patients with chronic functional constipation: a randomized, double-blind, placebo-controlled pilot clinical trial.

作者信息

Terrén Lora Ana, Penadés Bruno F, López Oliva Sara, Arponen Sari, Okutan Gülşah, Sánchez Niño Guerthy Melissa, San Mauro Martín Ismael

机构信息

Research Centers in Nutrition and Health (CINUSA Group), Research Department, Madrid, Spain.

Slow Medicine Institute, Research Department, Alcobendas, Madrid, Spain.

出版信息

Gastroenterol Rep (Oxf). 2024 Nov 11;12:goae101. doi: 10.1093/gastro/goae101. eCollection 2024.

Abstract

BACKGROUND

Functional constipation includes a set of gastrointestinal symptoms unexplainable by an identifiable underlying physical cause or pathology. The prevalence of this condition is high and there is a need to develop strategies to reduce it. Probiotics, prebiotics, and synbiotics may be an alternative treatment for chronic functional constipation.

METHODS

To compare the efficacy of dietary supplementation on symptoms of patients who suffer from chronic functional constipation. An exploratory, randomized, double-blind, placebo-controlled pilot clinical trial was conducted with 74 patients diagnosed with chronic functional constipation who were divided into four treatment groups-Group A: probiotics; Group B: prebiotics; Group C: synbiotics; Group D: placebo. Each patient was treated for 8 weeks. At the beginning and end of treatment, data were collected by administering questionnaires and scales, including the Bristol stool scale, on gastrointestinal symptoms, bowel movements, and sociodemographic and anthropometric characteristics.

RESULTS

Stool frequency increased in all four study groups, and greatest difference was observed in the synbiotics group (2.8 ± 1.3 vs. 5.9 ± 2.6;  < 0.001). Stool consistency improved only in the active treatment groups. Based on the evaluation of gastrointestinal symptoms, participants treated with prebiotics, probiotics and synbiotics showed the greatest improvement in abdominal pain (8.28 ± 2.63 vs. 6.56 ± 2.62;  = 0.009), gastroesophageal reflux (4.60 ± 2.66 vs. 3.45 ± 2.42;  = 0.039) and constipation symptoms (13.00 ± 3.97 vs. 8.71 ± 3.35;  = 0.003), respectively. As for quality of life, the main changes were observed in physical health domains, with a placebo effect.

CONCLUSIONS

The present study provides evidence supporting the efficacy of dietary supplementation with probiotics, prebiotics, and synbiotics in patients with chronic functional constipation after 8 weeks of treatment.

摘要

背景

功能性便秘包括一系列无法用可识别的潜在身体原因或病理状况解释的胃肠道症状。这种疾病的患病率很高,因此需要制定策略来降低其患病率。益生菌、益生元及合生元可能是慢性功能性便秘的一种替代治疗方法。

方法

为比较膳食补充剂对慢性功能性便秘患者症状的疗效。对74例诊断为慢性功能性便秘的患者进行了一项探索性、随机、双盲、安慰剂对照的临床试验,这些患者被分为四个治疗组——A组:益生菌;B组:益生元;C组:合生元;D组:安慰剂。每位患者接受8周治疗。在治疗开始和结束时,通过发放问卷和量表收集数据,包括布里斯托大便分类法、胃肠道症状、排便情况以及社会人口统计学和人体测量学特征。

结果

所有四个研究组的排便频率均增加,其中合生元组的差异最大(2.8±1.3对5.9±2.6;<0.001)。仅在积极治疗组中,粪便稠度得到改善。根据胃肠道症状评估,接受益生元、益生菌和合生元治疗的参与者在腹痛(8.28±2.63对6.56±2.62;=0.009)、胃食管反流(4.60±2.66对3.45±2.42;=0.039)和便秘症状(13.00±3.97对8.71±3.35;=0.003)方面改善最为明显。至于生活质量,主要变化出现在身体健康领域,存在安慰剂效应。

结论

本研究提供了证据,支持在治疗8周后,对慢性功能性便秘患者进行益生菌、益生元及合生元膳食补充具有疗效。

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