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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction

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