The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms

Sponsor

Eastern Mediterranean University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05566171

Collaborator

(none)

102

Enrollment

Location

Arms

7.9

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Dysfunction	Dietary Supplement: Activia Probiotic Yogurt	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The severity of gastrointestinal symptoms (mainly constipation) will decrease in the interventional group [4 weeks]
We expect to see improvement in the gastrointestinal symptoms after consuming probiotic yogurt

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nezire	Famagusta		Cyprus	99520

Sponsors and Collaborators

Eastern Mediterranean University

Investigators

Study Director: Nezire Ince, Eastern Mediterranean University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nezire İnce, Asst. Prof., Eastern Mediterranean University

ClinicalTrials.gov Identifier:

NCT05566171

Other Study ID Numbers:

2022-0179

First Posted:

Oct 4, 2022

Last Update Posted:

Oct 4, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nezire İnce, Asst. Prof., Eastern Mediterranean University

probiotic, gastrointestinal symptoms, constipation

Study Results

No Results Posted as of Oct 4, 2022