Short Bowel SyndromeSBS DISKNCT06771505
SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Questionnaire (SBS QoL)
An observational study of Short Bowel Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2025to 1 Jan 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will focus on adult patients with short bowel syndrome followed up in the GHS Intensive Clinical Nutrition Department, during a consultation, a day hospital or a conventional hospital stay.
Who may be able to join
- Age 18 or over
- Patient able to read and speak French
- Patient suffering from short bowel syndrome
Who cannot join
- Known cognitive disorders
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, 1 recruiting
- Recruiting
Hôpital Lyon Sud - CHLS
Pierre-Bénite, 69495
Charlotte BERGOIN, Doctor, +33 04.78.86.38.69, charlotte.bergoin@chu-lyon.fr
Stéphanie PECORA, Dietitian, +33 04.78.86.38.69, stephanie.pecora@chu-lyon.fr
About this study
Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). This tool may seem complex and tedious to use in everyday practice. However, it is important to regularly assess the quality of life of these patients. This is why the investigators are proposing to create a new tool for more rapid assessment of the quality of life of patients with short bowel syndrome.
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel syndrome, Quality of life
- Medical subject headings
- Short 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 |
|---|---|---|
| Questionnaire completion | The partient completes the two quality of life assessment questionnaires (Short Bowel Syndrome Quality of Life (SBS QoL) and SBS disk assessment tool), in paper format. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a new quality of life tool, the SBS disk, in comparison with a quality of life assessment tool, the SBS QoL.
Self-questionnaire in the form of a disk which covers 10 themes: Energy, stress level, anxiety, diet, abdominal pain, transit, appliances, social life, social and professional activity, sleep, as well as self-image and intimate life, according to the recommendations of the WHO quality of life assessment.
These themes are the same as those generally covered by the SBS QoL reference questionnaire, with the exception of self-image and intimacy.
The themes are evaluated according to the patient's feelings during the past week on a scale from 0 to 10.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start15 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte BERGOIN, Doctor, Principal investigator, Service d'hépato-gastro-entérologie et Assistance nutritionnelle - Hôpital Lyon Sud - CHLS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771505
- Sponsor's protocol ID
- 69HCL24_0889
- Other IDs
- 2024-A02032-45
- Acronym
- SBS DISK
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2025
- Last updated
- 12 Feb 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Questionnaire (SBS QoL)
- ClinicalTrials.gov ID
- NCT06771505
- Acronym / sponsor ID
- SBS DISK / 69HCL24_0889
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel syndrome, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Jan 2025 (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.
Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). This tool may seem complex and tedious to use in everyday practice. However, it is important to regularly assess the quality of life of these patients. This is why the investigators are proposing to create a new tool for more rapid assessment of the quality of life of patients with short bowel syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire completion | – | –The partient completes the two quality of life assessment questionnaires (Short Bowel Syndrome Quality of Life (SBS QoL) and SBS disk assessment tool), in paper format. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will focus on adult patients with short bowel syndrome followed up in the GHS Intensive Clinical Nutrition Department, during a consultation, a day hospital or a conventional hospital stay.
Key inclusion criteria (3 listed)
- Age 18 or over
- Patient able to read and speak French
- Patient suffering from short bowel syndrome
Key exclusion criteria (1 listed)
- Known cognitive disorders
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
Validation of a new quality of life tool, the SBS disk, in comparison with a quality of life assessment tool, the SBS QoL.
Time frame: Day 1
Self-questionnaire in the form of a disk which covers 10 themes: Energy, stress level, anxiety, diet, abdominal pain, transit, appliances, social life, social and professional activity, sleep, as well as self-image and intimate life, according to the recommendations of the WHO quality of life assessment. These themes are the same as those generally covered by the SBS QoL reference questionnaire, with the exception of self-image and intimacy. The themes are evaluated according to the patient's feelings during the past week on a scale from 0 to 10.
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 12 Feb 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.
Charlotte BERGOIN, Doctor principal investigator
Service d'hépato-gastro-entérologie et Assistance nutritionnelle - Hôpital Lyon Sud - CHLS
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 Short Bowel Syndrome, run by Hospices Civils de Lyon 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 3 inclusion and 1 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 12 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 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 Charlotte BERGOIN, Doctor (+33 04.78.86.38.69, charlotte.bergoin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a new quality of life tool, the SBS disk, in comparison with a quality of life assessment tool, the SBS QoL. (time frame: Day 1). 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 12 Feb 2026.