Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07441629

Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score.

The goal of this qualitative study is to identify and better understand the symptoms of stricturing Crohn's disease in order to inform the development of more appropriate clinical evaluation scores. This study focuses on adult patients diagnosed with stricturing Crohn's disease who are followed in hospital gastroenterology departments.

The main questions it aims to answer are:

* Which symptoms are perceived by patients as the most specific and significant features of stenosing Crohn's disease? * Which symptoms are perceived by patients as early warning signs of a stenosing flare? * How does stenosing Crohn's disease impact daily life, mental health, and quality of life, and what coping strategies do patients use to manage symptoms and limit their impact?

Participants will:

* Take part in a one-hour individual semi-structured interview, conducted in person (at the hospital, at home, or in another agreed location) or by videoconference * Have the interview audio-recorded for transcription and qualitative analysis * Be offered the opportunity to review and validate the transcript and summary of their interview before final anonymized analysis

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (≥ 18 years old).
  • With a confirmed diagnosis of Crohn's disease.
  • Presenting a stricturing form of the disease (confirmed clinically, endoscopically, radiologically, or surgically).
  • Followed in a hospital department managing inflammatory bowel diseases (IBD).
  • Clinically stable at the time of the interview (not experiencing an acute episode requiring urgent hospitalization).
  • Able to understand and speak French, in order to participate in a qualitative interview.

Exclusion criteria

  • Current hospitalization for a severe Crohn's disease flare, acute intestinal obstruction, or any situation requiring urgent medical care.
  • Severe cognitive impairment, communication deficits, or acute psychiatric disorder preventing understanding of the interview or reliable expression of experiences.
  • Major uncontrolled medical comorbidity (e.g., active cancer under treatment, severe heart failure) making the interview inappropriate or likely to confound symptom interpretation.
  • Technical inability to participate in an interview (no access to the proposed modalities: unable to travel, no access to videoconference if a remote interview is required).
  • Pregnant women
  • Persons deprived of their liberty
  • Persons receiving psychiatric care
  • Persons admitted to a healthcare or social institution
  • Adults subject to a legal protection measure
  • Persons unable to express their consent

Treatment and study plan

semi-structured interview

Other

One-hour semi-structured interview in person or by videoconference. Interviews will be audio-recorded, pseudonymized, transcribed, and analyzed, and participants can review their transcripts before final anonymization.

Primary outcomes

  1. Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews.

    Time frame: Up to 5 months

Secondary outcomes

  1. Frequency of patient-reported symptom categories described as early warning signs of a stenosing flare, derived from qualitative content analysis of individual interviews.

    Time frame: Up to 5 months

  2. Frequency of patient-reported daily life impact domains identified through qualitative content analysis of individual interviews.

    Time frame: Up to 5 months

  3. Frequency of patient-reported mental health impact domains identified through qualitative content analysis of individual interviews.

    Time frame: Up to 5 months

  4. Frequency of patient-reported quality-of-life impact domains identified through qualitative content analysis of single semi-structured interviews.

    Time frame: Up to 5 months

  5. Frequency of patient-reported coping strategy categories identified through qualitative content analysis of individual interviews.

    Time frame: Up to 5 months

Study contacts

Contact information is provided by the study sponsor or research team.

Zahra Moussavi

CONTACT

[email protected]

+33 4 76 76 86 41

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: SYMCROHNS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.