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Enrolling by invitationNCT07436910Updated Feb 27, 2026

Health-Related Quality of Life Among Patients With Inflammatory Bowel Disease

An observational study in Irritable Bowel Disease, Ulcerative Colitis (UC) and Crohn Disease (CD), sponsored by Cairo University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
385
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Irritable Bowel Disease
  • Ulcerative Colitis (UC)
  • Crohn Disease (CD)

Keywords

  • HRQOL
  • IBD
  • QLQ-SWB
  • UC
  • CD
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 385 is above the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The target population will be adult patients diagnosed with IBD in Egypt.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Have a diagnosis of indeterminate colitis.
  • Have any other chronic inflammatory conditions.
  • Have severe cognitive impairment that hinders their ability to complete the questionnaires.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
385 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Single time point, one-time data collection

  2. 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.

    Time frame: Single time point, one-time data collection

  3. 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.

    Time frame: Single time point, one-time data collection

Secondary outcomes

  1. Perceived Social Support

    The Oslo Social Support Scale (OSSS-3) is a three-item measure of social support.

    Time frame: Single time point, one-time data collection

  2. Percived Self-Efficacy

    A reliable and validated General Self-Efficacy Short Scale-3 (GSE-3) will be used.

    Time frame: Single time point, one-time data collection

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07436910
Lead sponsor
Cairo University
Responsible party
Naglaa Fathy Afifi Youssef (Professor, Cairo University) — Principal investigator
First posted
Feb 27, 2026
Start date
Sep 1, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Naglaa Youssef
principal investigator · Faculty of Nursing, Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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