Crohn Disease (CD)SYMCROHNSNCT07441629
Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score.
An observational study of Crohn Disease (CD), run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Semi-structured interview
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to Nov 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: Adult patient (≥ 18 years old), with a confirmed diagnosis of Crohn's disease presenting a stricturing form of the disease
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Grenoble Alpes
La Tronche, 38700
Anna Borowik, PhD, +33 4 76 76 93 14, aborowik@chu-grenoble.fr
About this study
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:
Read more
- 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
- Conditions
- Crohn Disease (CD)
- Being tested
- Semi-structured interview
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews.
Measured: Up to 5 months
Secondary outcomes (5)
Frequency of patient-reported symptom categories described as early warning signs of a stenosing flare, derived from qualitative content analysis of individual interviews.
Measured: Up to 5 months
Frequency of patient-reported daily life impact domains identified through qualitative content analysis of individual interviews.
Measured: Up to 5 months
Frequency of patient-reported mental health impact domains identified through qualitative content analysis of individual interviews.
Measured: Up to 5 months
Frequency of patient-reported quality-of-life impact domains identified through qualitative content analysis of single semi-structured interviews.
Measured: Up to 5 months
Frequency of patient-reported coping strategy categories identified through qualitative content analysis of individual interviews.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441629
- Sponsor's protocol ID
- 38RC25.0402
- Acronym
- SYMCROHNS
- Status last verified
- May 2026
- First submitted
- 16 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to the qualitative nature of the study. The data consist of interview transcripts containing health-related information and sensitive personal content. Full anonymization cannot be guaranteed, and data sharing was not covered by the informed consent or the European regulatory framework (GDPR) applicable to this study.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score.
- ClinicalTrials.gov ID
- NCT07441629
- Acronym / sponsor ID
- SYMCROHNS / 38RC25.0402
- Conditions
- Crohn Disease (CD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Mar 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 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥ 18 years old), with a confirmed diagnosis of Crohn's disease presenting a stricturing form of the disease
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Semi-structured interviewOne-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. | Other | – |
Primary outcome
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
5 secondary outcomes
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
Frequency of patient-reported daily life impact domains identified through qualitative content analysis of individual interviews.
Time frame: Up to 5 months
Frequency of patient-reported mental health impact domains identified through qualitative content analysis of individual interviews.
Time frame: Up to 5 months
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
Frequency of patient-reported coping strategy categories identified through qualitative content analysis of individual interviews.
Time frame: Up to 5 months
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 20 May 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to the qualitative nature of the study. The data consist of interview transcripts containing health-related information and sensitive personal content. Full anonymization cannot be guaranteed, and data sharing was not covered by the informed consent or the European regulatory framework (GDPR) applicable to this study.
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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.
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 Crohn Disease (CD), run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 20 May 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 France. 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 Zahra Moussavi (+33 4 76 76 86 41, zmoussavi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 20 May 2026.