Gastrointestinal DysfunctionNCT05566171
The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms
A study testing Activia Probiotic Yogurt in people with Gastrointestinal Dysfunction, run by Eastern Mediterranean University at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- Activia Probiotic Yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Having diagnosed gastrointestinal disease
- Regular consumption of probiotic
- Using of drug that affects gastrointestinal system
- Presence of mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Activia Probiotic Yogurt
- Keywords
- probiotic, gastrointestinal symptoms, constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activia Probiotic YogurtDietary supplement
Activia probiotic Yogurt will be consumed by participants in this group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Activia Probiotic Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Mar 2025
Why it stopped: My colleague did not want to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezire İnce, Eastern Mediterranean University
- Investigators
- Nezire Ince, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566171
- Sponsor's protocol ID
- 2022-0179
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms Among People Aged 19-64 Years
- ClinicalTrials.gov ID
- NCT05566171
- Acronym / sponsor ID
- 2022-0179
- Conditions
- Gastrointestinal Dysfunction
- Keywords
- probiotic, gastrointestinal symptoms, constipation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: My colleague did not want to continue the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will be just follow-up for 4 weeks without any intervention |
| Interventional Group | Experimental | Dietary Supplement: Activia Probiotic YogurtThis group will consume 125 g plain Activia Probiotic Yogurt without any aroma/fruit during 4 weeks/1 month |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Having diagnosed gastrointestinal disease
- Regular consumption of probiotic
- Using of drug that affects gastrointestinal system
- Presence of mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activia Probiotic YogurtActivia probiotic Yogurt will be consumed by participants in this group | Dietary supplement | Interventional Group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nezire Ince study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activia Probiotic Yogurt in people with Gastrointestinal Dysfunction, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of gastrointestinal symptoms (mainly constipation) will decrease in the interventional group (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.