Irritable Bowel DiseaseNCT07436910
Health-Related Quality of Life Among Patients With Inflammatory Bowel Disease
An observational study of Irritable Bowel Disease and Ulcerative Colitis (UC), run by Cairo University at 1 site in Egypt.
Trial summary
The primary aim of this study is to assess HRQOL and its associated factors among people with IBD. The target sample will be 385 adult patients diagnosed with IBD (both Crohn's Disease and Ulcerative Colitis). The data will be collected using a self-administered survey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Disease, Ulcerative Colitis (UC), Crohn Disease (CD)
- How many people
- 385 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population will be adult patients diagnosed with IBD in Egypt.
Who may be able to join
- 18 years or older.
- Have a confirmed diagnosis of IBD.
- Can understand and complete the study questionnaires.
- Provide written informed consent to participate in the study.
Who cannot join
- Have a diagnosis of indeterminate colitis.
- Have any other chronic inflammatory conditions.
- Have severe cognitive impairment that hinders their ability to complete the questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Health-Related Quality of Life and Associated Factors Among Patients With Inflammatory Bowel Disease: Cross-Sectional Multicentre Study
The primary aim of this study is to assess HRQOL and its associated factors among people with IBD. The target sample will be 385 adult patients diagnosed with IBD (both Crohn's Disease and Ulcerative Colitis). The data will be collected using a self-administered survey.
Read the detailed description
The target population will be adult patients diagnosed with IBD. Participants will receive full information about the study's purpose, the voluntary nature of their participation, and the complete confidentiality of their data, including the right to withdraw at any point without explanation. Informed written consent will be obtained from each participant before they complete the questionnaires. Collected data will be stored securely on a password-protected computer and anonymized through coding.
Descriptive and inferential statistics will be used to analyze the data.
- Keywords
- HRQOL, IBD, QLQ-SWB, UC, CD
- Medical subject headings
- Irritable Bowel Syndrome, Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirituality well-being
The SWB scale has 32 items. All scales range from 0 to 100, with high scores representing positive spirituality. The SWB scale demonstrated strong reliability and validity.
Measured: Single time point, one-time data collection
Demographic and clinical characteristics
Basic sociodemographic data, including the setting of data collection, age, sex, religion, education, and employment status. Clinical data, including the type of IBD, age of IBD diagnosis, and comorbidity.
Measured: Single time point, one-time data collection
HRQOL
The Inflammatory Bowel Diseases Disability Index (IBD-DI) Disk is a brief version of the IBD-DI that allows assessing patients' self-perceived disability. It includes 10 domains: abdominal pain, energy, interpersonal interactions, bowel regulation, body image, sexual function, emotions, sleep, education/work, and joint pain. It has satisfactory validity and reliability.
Measured: Single time point, one-time data collection
Secondary outcomes (2)
Perceived Social Support
The Oslo Social Support Scale (OSSS-3) is a three-item measure of social support.
Measured: Single time point, one-time data collection
Percived Self-Efficacy
A reliable and validated General Self-Efficacy Short Scale-3 (GSE-3) will be used.
Measured: Single time point, one-time data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Fathy Afifi Youssef, Cairo University
- Investigators
- Naglaa Youssef, Principal investigator, Faculty of Nursing, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436910
- Sponsor's protocol ID
- REC-2025-0006
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life and Associated Factors Among Patients With Inflammatory Bowel Disease: Cross-Sectional Multicentre Study
- ClinicalTrials.gov ID
- NCT07436910
- Acronym / sponsor ID
- REC-2025-0006
- Keywords
- HRQOL, IBD, QLQ-SWB, UC, CD
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Feb 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.
The primary aim of this study is to assess HRQOL and its associated factors among people with IBD. The target sample will be 385 adult patients diagnosed with IBD (both Crohn's Disease and Ulcerative Colitis). The data will be collected using a self-administered survey.
Detailed description
The target population will be adult patients diagnosed with IBD. Participants will receive full information about the study's purpose, the voluntary nature of their participation, and the complete confidentiality of their data, including the right to withdraw at any point without explanation. Informed written consent will be obtained from each participant before they complete the questionnaires. Collected data will be stored securely on a password-protected computer and anonymized through coding.
Descriptive and inferential statistics will be used to analyze the data.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be adult patients diagnosed with IBD in Egypt.
Key inclusion criteria (4 listed)
- 18 years or older.
- Have a confirmed diagnosis of IBD.
- Can understand and complete the study questionnaires.
- Provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Have a diagnosis of indeterminate colitis.
- Have any other chronic inflammatory conditions.
- Have severe cognitive impairment that hinders their ability to complete the questionnaires.
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
Spirituality well-being
Time frame: Single time point, one-time data collection
The SWB scale has 32 items. All scales range from 0 to 100, with high scores representing positive spirituality. The SWB scale demonstrated strong reliability and validity.
Demographic and clinical characteristics
Time frame: Single time point, one-time data collection
Basic sociodemographic data, including the setting of data collection, age, sex, religion, education, and employment status. Clinical data, including the type of IBD, age of IBD diagnosis, and comorbidity.
HRQOL
Time frame: Single time point, one-time data collection
The Inflammatory Bowel Diseases Disability Index (IBD-DI) Disk is a brief version of the IBD-DI that allows assessing patients' self-perceived disability. It includes 10 domains: abdominal pain, energy, interpersonal interactions, bowel regulation, body image, sexual function, emotions, sleep, education/work, and joint pain. It has satisfactory validity and reliability.
2 secondary outcomes
Perceived Social Support
Time frame: Single time point, one-time data collection
Percived Self-Efficacy
Time frame: Single time point, one-time data collection
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 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Disease
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Naglaa Youssef principal investigator
Faculty of Nursing, Cairo 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 Irritable Bowel Disease and Ulcerative Colitis (UC), run by Cairo University at 1 site in Egypt.
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 3 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 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 Egypt. 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?
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?
Spirituality well-being (time frame: Single time point, one-time data collection). The study lists 3 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 27 Feb 2026.