ConstipationNCT07870915
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
An observational study of Constipation and Irritable Bowel Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional, observational, controlled comparative study aims to investigate the relationship between interoception and postural control in individuals with constipation-predominant irritable bowel syndrome (IBS-C) and to compare the findings with those of healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Irritable Bowel Disease
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals aged 18-45 years with a clinical diagnosis of constipation-predominant irritable bowel syndrome (IBS-C) and healthy volunteers with similar age and sex characteristics.
Who may be able to join
- Aged 18-45 years.
- For the IBS-C group, having a clinical diagnosis of constipation-predominant irritable bowel syndrome.
- For the control group, having no history of gastrointestinal disease.
- Voluntarily agreeing to participate in the study.
Who cannot join
- Having a neurological, rheumatological, or serious orthopedic disease.
- Having a history of surgery that may affect posture.
- Pregnancy.
- Being unable to complete the assessments due to cognitive or communication impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mehmet Burak Uyaroğlu, Asst Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Topkapı University
Istanbul
Mehmet Mahir Atasoy, Prof, 0543 380 60 70, info@dratasoy.com
About this study
Official title: Investigation of the Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
This cross-sectional, observational, controlled comparative study aims to investigate the relationship between interoception and postural control in individuals with constipation-predominant irritable bowel syndrome (IBS-C) and to compare the findings with those of healthy individuals. Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), postural characteristics will be evaluated using the Corbin Posture Analysis, and stool type in the IBS-C group will be assessed using the Bristol Stool Scale.
Read the detailed description
This study is designed as a cross-sectional, observational, controlled comparative study. The study population will consist of individuals aged 18-45 years with a diagnosis of constipation-predominant irritable bowel syndrome (IBS-C) and healthy volunteers with similar age and sex characteristics.
The sample size was calculated using G*Power 3.1.9.7 based on a medium effect size (d=0.50), a significance level of 5% (α=0.05), and a statistical power of 80% (1-β=0.80). A total of 128 participants, with at least 64 participants in each group, are planned to be included.
After written informed consent is obtained, participants will complete a sociodemographic information form. Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2). Stool type will be evaluated using the Bristol Stool Scale in the IBS-C group, and posture will be assessed in all participants using the Corbin Posture Analysis.
The collected data will be analyzed using descriptive statistics, tests of normality, between-group comparison tests, correlation analyses, and multivariable regression analyses. Statistical significance will be set at p<0.05.
- Conditions
- Constipation, Irritable Bowel Disease
- Keywords
- irritable bowel disease, posture, interoception
- Medical subject headings
- Constipation, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Constipation-Predominant Irritable Bowel Syndrome Group | Individuals aged 18-45 years with a clinical diagnosis of constipation-predominant irritable bowel syndrome (IBS-C). | |
| Healthy Control Group | Healthy volunteers aged 18-45 years with similar age and sex characteristics to the IBS-C group and with no history of gastrointestinal disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interoceptive Awareness
Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2), a 37-item self-report questionnaire with 8 subscales (Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, Trusting). Each item is rated from 0 (never) to 5 (always), and the unit of measure is the mean score of each subscale (range 0 to 5). Higher scores indicate better interoceptive awareness.
Measured: Baseline (single assessment at study enrollment).
Postural Characteristics
Posture will be assessed by an examiner using the Corbin Posture Analysis, an observational posture evaluation in which body segments are rated against a standard postural alignment. The unit of measure is the total posture score (range: 0 to 20). Higher scores indicate worse posture.
Measured: Baseline (single assessment at study enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Altınkaynak, Istanbul Topkapi University
- Investigators
- Gamze Koyutürk, Asst Prof, Principal investigator, Topkapı UniversityMehmet B Uyaroğlu, Asst Prof, Study director, Fenerbahce UniversityGörkem Dizdar, Asst Prof, Study chair, Topkapı UniversityMehmet M Atasoy, Prof, Study chairBeyza Erdogmus, Dr, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870915
- Sponsor's protocol ID
- TopkapıUniv
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07870915
- Acronym / sponsor ID
- TopkapıUniv
- Conditions
- Constipation, Irritable Bowel Disease
- Keywords
- irritable bowel disease, posture, interoception
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
This cross-sectional, observational, controlled comparative study aims to investigate the relationship between interoception and postural control in individuals with constipation-predominant irritable bowel syndrome (IBS-C) and to compare the findings with those of healthy individuals. Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), postural characteristics will be evaluated using the Corbin Posture Analysis, and stool type in the IBS-C group will be assessed using the Bristol Stool Scale.
Detailed description
This study is designed as a cross-sectional, observational, controlled comparative study. The study population will consist of individuals aged 18-45 years with a diagnosis of constipation-predominant irritable bowel syndrome (IBS-C) and healthy volunteers with similar age and sex characteristics.
The sample size was calculated using G*Power 3.1.9.7 based on a medium effect size (d=0.50), a significance level of 5% (α=0.05), and a statistical power of 80% (1-β=0.80). A total of 128 participants, with at least 64 participants in each group, are planned to be included.
After written informed consent is obtained, participants will complete a sociodemographic information form. Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2). Stool type will be evaluated using the Bristol Stool Scale in the IBS-C group, and posture will be assessed in all participants using the Corbin Posture Analysis.
The collected data will be analyzed using descriptive statistics, tests of normality, between-group comparison tests, correlation analyses, and multivariable regression analyses. Statistical significance will be set at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constipation-Predominant Irritable Bowel Syndrome Group | – | –Individuals aged 18-45 years with a clinical diagnosis of constipation-predominant irritable bowel syndrome (IBS-C). |
| Healthy Control Group | – | –Healthy volunteers aged 18-45 years with similar age and sex characteristics to the IBS-C group and with no history of gastrointestinal disease. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals aged 18-45 years with a clinical diagnosis of constipation-predominant irritable bowel syndrome (IBS-C) and healthy volunteers with similar age and sex characteristics.
Key inclusion criteria (4 listed)
- Aged 18-45 years.
- For the IBS-C group, having a clinical diagnosis of constipation-predominant irritable bowel syndrome.
- For the control group, having no history of gastrointestinal disease.
- Voluntarily agreeing to participate in the study.
Key exclusion criteria (4 listed)
- Having a neurological, rheumatological, or serious orthopedic disease.
- Having a history of surgery that may affect posture.
- Pregnancy.
- Being unable to complete the assessments due to cognitive or communication impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interoceptive Awareness
Time frame: Baseline (single assessment at study enrollment).
Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2), a 37-item self-report questionnaire with 8 subscales (Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, Trusting). Each item is rated from 0 (never) to 5 (always), and the unit of measure is the mean score of each subscale (range 0 to 5). Higher scores indicate better interoceptive awareness.
Postural Characteristics
Time frame: Baseline (single assessment at study enrollment).
Posture will be assessed by an examiner using the Corbin Posture Analysis, an observational posture evaluation in which body segments are rated against a standard postural alignment. The unit of measure is the total posture score (range: 0 to 20). Higher scores indicate worse posture.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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.
Mehmet Burak Uyaroğlu, Asst Prof contact
Gamze Koyutürk, Asst Prof principal investigator
Topkapı University
Mehmet B Uyaroğlu, Asst Prof study director
Fenerbahce University
Görkem Dizdar, Asst Prof study chair
Topkapı University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Irritable Bowel Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamze Koyutürk, Asst Prof (+905065798671, gamzealtinkaynak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoceptive Awareness (time frame: Baseline (single assessment at study enrollment).). The study lists 2 primary outcomes in all. 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 21 Oct 2026.