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Clinical Trials/NCT05566171
NCT05566171WithdrawnNot Applicable

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

Eastern Mediterranean University1 site in 1 country102 target enrollmentStarted: September 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
102
Locations
1
Primary Endpoint
The severity of gastrointestinal symptoms (mainly constipation) will decrease in the interventional group

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Activia Probiotic Yogurt (Dietary Supplement)

Outcomes

Primary Outcomes

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

Time Frame: 4 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nezire İnce

Asst. Prof.

Eastern Mediterranean University

Study Sites (1)

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