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临床试验/NCT05566171
NCT05566171撤回不适用

The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms Among People Aged 19-64 Years

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
102
试验地点
2
主要终点
The severity of gastrointestinal symptoms (mainly constipation) will decrease in the interventional group

研究概览

简要总结

Probiotics have beneficial effect on Gastrointestinal Symptoms. The aim of this study is to determine the effect of probiotic yogurt consumptions on the people who have gastrointestinal symptoms mainly constipation.

详细描述

In the beginning of the study Constipation Severity Scale and Bristol Stool Scale was applied to the all people who accepted to participate in this study. According to the student T test analysis (α= 0.05, β=0.20 ) 102 people with gastrointestinal symtoms should be included in the study. When 102 people are found with gastrointestinal symptoms second stage of the study will begin. In this stage of the study 102 people are randomly divided into 2 homogeneous groups. 3 day food record will be taken from 102 people at the beginning and again at the end of the study. Probiotic yogurt (Activia Probiotic Yogurt without any aroma-125 g) will be given to one group for 1 month and nothing will be given to the other group (control group).

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
Single (Participant)

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Living in Izmir
  • Individuals who are having BMI between 18.5-24.9 kg / m2
  • Having gastrointestinal symptoms according to Constipation Severity Scale and Bristol Stool Scale

排除标准

  • Having diagnosed gastrointestinal disease
  • Regular consumption of probiotic
  • Using of drug that affects gastrointestinal system
  • Presence of mental illness

研究组 & 干预措施

Control Group

No Intervention

This group will be just follow-up for 4 weeks without any intervention

Interventional Group

Experimental

This group will consume 125 g plain Activia Probiotic Yogurt without any aroma/fruit during 4 weeks/1 month

干预措施: Activia Probiotic Yogurt (Dietary Supplement)

结局指标

主要结局

The severity of gastrointestinal symptoms (mainly constipation) will decrease in the interventional group

时间窗: 4 weeks

We expect to see improvement in the gastrointestinal symptoms after consuming probiotic yogurt

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nezire İnce

Asst. Prof.

Eastern Mediterranean University

研究点 (2)

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