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NCT05566171 Clinical Trial

The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms

Gastrointestinal Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05566171
Other study ID # 2022-0179
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date March 30, 2025

Study information
Verified date February 2024
Source Eastern Mediterranean University
Contact Nezire Ince
Phone 05428692402
Email nezire.ince@emu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 102
Est. completion date March 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 64 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having diagnosed gastrointestinal disease - Regular consumption of probiotic - Using of drug that affects gastrointestinal system - Presence of mental illness

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Activia Probiotic Yogurt
Activia probiotic Yogurt will be consumed by participants in this group

Locations
Country Name City State
Cyprus Nezire Famagusta

Sponsors (1)
Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome
Type Measure Description Time frame Safety issue
Primary The severity of gastrointestinal symptoms (mainly constipation) will decrease in the interventional group We expect to see improvement in the gastrointestinal symptoms after consuming probiotic yogurt 4 weeks
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