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临床试验/NCT01173588
NCT01173588已完成3 期

Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function: A Randomized, Double-blind, Longitudinal Controlled Study in Mexican Adult.

Instituto Lala1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2007年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
174
试验地点
1
主要终点
Stools Frequency

研究概览

简要总结

The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.

详细描述

The use of probiotics and prebiotics has become popular in human nutrition and food product development. The most common probiotics are Lactobacillus and Bifidobacterium species. Bifidobacteria spp are dominant in the intestinal microflora and are considered to be beneficial to the host, for this reason research efforts have focused on increasing their proportion in the intestinal microflora through oral administration of mixtures containing bifidobacteria or oral supplementation with prebiotics. An important limitation for the effectiveness of oral probiotics is that they might be destroyed during digestion in the gastrointestinal tract therefore and adequate vehicle could improve its potential benefits. Yogurt is a suitable vehicle for the administration of bifidobacteria, due to its physicochemical properties, such as pH and nutrients content, as well as the organoleptic properties that contribute to its increasing consumption. Thus simultaneous administration of probiotics and prebiotics in a suitable vehicle could act synergistically and may have potential for improving gut health. Few clinical trials have been performed using prebiotics and probiotics. The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age between 18 and 55 years,
  • •be free of known gastrointestinal diseases,
  • •desist of consuming prebiotic and/or probiotic-containing foods or dietary supplements during the entire duration of the study,
  • •agree to avoid any medication that produced changes in gastrointestinal function, diarrhea or constipation until completion of the study,
  • •be willing to complete all necessary study questionnaires,
  • •accept voluntary participation and sign a written informed consent before inclusion in the study.

排除标准

  • •subjects receiving any kind of treatment that may had altered bowel function;
  • •intake of laxatives,
  • •a concomitant sever gastrointestinal disease;
  • •that were consuming probiotics and/or prebiotics-containing foods or dietary supplements within the two previous weeks;
  • •subjects were also excluded if they had received any antimicrobial medication during the previous 2 months.

研究组 & 干预措施

Yogurt+fiber+probiotic

Experimental

Yogurt YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL

干预措施: yogurt added with bifidobacteria and soluble fiber (YBF) (Other)

regular yogurt

Placebo Comparator

yogurt YR had no additional fiber or bifidobacterium

干预措施: yogurt added with bifidobacteria and soluble fiber (YBF) (Other)

结局指标

主要结局

Stools Frequency

时间窗: 0, 1, 2, 3, 4, 5 weeks

Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times

次要结局

  • Consistency of stools(0, 1, 2, 3, 4, 5 weeks)
  • Difficulty of defecation(0,1,2,3,4,5)
  • Abdominal distension(0,1,2,3,4,5)
  • Flatulence(0,1,2,3,4,5)
  • Abdominal pain(0,1,2,3,4,5 weeks)

研究者

发起方
Instituto Lala
申办方类型
Industry

研究点 (1)

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