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临床试验/NCT01587846
NCT01587846Unknown3 期

Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children - Randomized, Double Blind, Placebo Controlled Study

Sisters of Mercy University Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
300
试验地点
2
主要终点
Intensity of abdominal pain

研究概览

简要总结

Beneficial therapeutic effect of probiotics has been reported in children with irritable bowel syndrome, but not consistently in other functional gastrointestinal disorders. Although there is evidence that probiotics increase stool frequency and decrease stool consistency in healthy individuals the evidence for efficacy in constipation is limited.

Children with functional abdominal pain (FAP) and constipation will be included in the study. Children with FAP will be randomized in one of two groups and will receive either L. reuteri in a daily dose of 108 CFU, or placebo during three months. Children with chronic constipation will receive either L. reuteri in a daily dose of 108 CFU and lactulose, or placebo and lactulose. Frequency and intensity of episodes of abdominal pain during and after intervention will be recorded in children with FAP. Frequency of defecation, stool consistency and need for lactulose will be recorded in children with chronic constipation.

详细描述

Part I. Lactobacillus reuteri in treatment of functional abdominal pain in children

  1. Introduction

Probiotics are defined as live microorganisms which confer a beneficial health effect on a human host. Their beneficial effects are based on: promotion of resistance to enteric pathogens, prevention of small bowel bacterial overgrowth and immune system modulation. The most commonly used probiotics are bacteria of genera Lactobacillus or Bifidobacterium. Other nonpathogenic genera, including Escherichia, Enterococcus and Bacillus, and nonbacterial organisms, such as a nonpathogenic yeast Saccharomyces boulardii, have also been studied.

A probiotic preparation must contain a certain minimum number of colony-forming units (CFU) per dose (4). Doses used in therapeutic and preventive trials vary. A daily intake of 1.000.000 to 1.000.000.000 CFUs is a reported minimum for therapeutic purposes. There is an increasing number of studies on beneficial effects of probiotics in treatment of acute infectious diarrhoea, and prevention of antibiotic associated diarrhoea. Role of probiotics in the treatment of functional GI disorders is still controversial.

Recurrent or chronic abdominal pain affects 10-15% of school-age children. Functional abdominal pain (FAP) is defined as occasional or continuous abdominal pain with a frequency of at least once a weak during at least two months; most frequently the pain is located around umbilicus and not related to meals. Although visceral hypersensitivity plays a certain role in pathogenesis of a pain, FAP is probably a complex disorder. Irritable bowel syndrome is defined as abdominal pain or discomfort associated (in at least 25% of time) with two of these criteria: 1) relief after defecation, 2) change in stool frequency or 3) change in stool consistence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with functional abdominal pain (age 4-18 years)
  • Children with chronic constipation (age 2-18 years)

排除标准

  • Immunodeficiency
  • Receiving probiotic and/or prebiotic products 7 days prior to enrolment
  • Neoplasms
  • Chronic disorders
  • Presence of "red flags":
  • Weight loss of more than 10%
  • Growth retardation or growth failure
  • Extraintestinal symptoms (fever, rash, joint pain, aphthae, affection of the urinary system)
  • Frequent vomiting
  • Abnormalities in laboratory findings (anemia, elevated ESR)
  • Abnormalities in clinical findings (organomegaly, perianal disease)

结局指标

主要结局

Intensity of abdominal pain

时间窗: 3 months

Pain score on visual-analogue scale during treatment

Severity of chronic constipation

时间窗: 3 months

Stool consistency score on Bristol stool scale during treatment

次要结局

  • Intensity of abdominal pain after treatment(1 month)
  • Severity of chronic constipation after treatment(1 month)

研究者

发起方
Sisters of Mercy University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanja Kolacek, MD, PhD

Head of the Department of Pediatrics, Clinical Professor, Principal Investigator

Sisters of Mercy University Hospital

研究点 (2)

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