The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Dysfunction
• Intervention / Treatment: Dietary supplement: Activia Probiotic Yogurt

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nezire Ince; Phone Number: 05428692402; Email: nezire.ince@emu.edu.tr

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99520
    • Nezire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; This group will be just follow-up for 4 weeks without any intervention
Experimental: Interventional Group; This group will consume 125 g plain Activia Probiotic Yogurt without any aroma/fruit during 4 weeks/1 month	Dietary supplement: Activia Probiotic Yogurt; Activia probiotic Yogurt will be consumed by participants in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Director: Nezire Ince, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: probiotic, gastrointestinal symptoms, constipation
• Other Study ID Numbers: 2022-0179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No