Short Bowel SyndromeSARCO-SGCNCT05441345
Sarcopenia and Short Bowel Syndrome
An observational study of Short Bowel Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- questionnaires with collection of stool and urine
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2022to 16 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 patients in CMS cared for and followed in the gastroenterology and nutritional assistance department of Beaujon Hospital
Who may be able to join
- Age ≥18 years old
- SBS diagnosis validated by small bowel length and either type 1 (enterostomy), type 2 or 3 (jejuno-colic or -ileal anastomosis)
- Patient not objecting to the collection of personal data as part of the study
Who cannot join
- Pregnancy
- Remaining hail length unknown
- Patient expressing opposition to participating in the cohort
- Patients who are unable to express themselves
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis
Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS.
Read the detailed description
Patients with short bowel syndrome (SBS) will be screened and included in longitudinal or cross-sectional studies if eligible.
The longitudinal study will follow patients with type 1 SBS (enterostomy) before and every 3 months after continuity surgery for 1 year. Cross-sectional studies will follow patients with type 2 or 3 SBS (jejunocolonic or -ileal anastomosis) for 1 year (every 3 months during the first 2 years after continuity surgery or every 6 months after).
Study visits will include clinical examination, nutritional assessment, endoscopy with biopsies and/or intestinal absorption assessment planned as part of routine follow-up. In addition, questionnaires will be completed (GPAQ, SarQoL, EQ-5D -3L, SF36), with collection of stool (for routine and research) and urine samples (for research).
The objective are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS. The results may identify metabolic or microbial biomarkers and predictors of nutritional optimisation in SBS, which is a complex and costly orphan disease.
- Conditions
- Short Bowel Syndrome
- Being tested
- questionnaires with collection of stool and urine
- Keywords
- Sarcopenia, short bowel syndrome, adaptation
- Medical subject headings
- Short Bowel Syndrome, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires with collection of stool and urineOther
questionnaires will be completed (GPAQ, SarQoL, EQ-5D-3L, SF36), with collection of stool (for care and research) and urine
| Study group | Role | What they receive |
|---|---|---|
| SBS patients | Not described Receives: Other: questionnaires with collection of stool and urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of sarcopenia
Changes in muscle strength (Jamar's dynamometer)
Measured: at 12 months
Evolution of sarcopenia
Changes in muscle mass (bioimpedance analysis)
Measured: at 12 months
Secondary outcomes (10)
Impact of sarcopenia
Changes in questionnaire of quality of life SarQoL
Measured: at 12 months
Impact of sarcopenia
Changes in questionnaire of quality of life EQ-5D-3L
Measured: at 12 months
Impact of sarcopenia
Changes in questionnaire of quality of life SF36
Measured: at 12 months
Impact of sarcopenia
Changes in questionnaire of physical activity (GPAQ)
Measured: at 12 months
Link with intestinal adaptation
Number of changes in histological markers of adaptation in relation to sarcopenia. Each of these elements can be considered as a chang : crypt depths, villi length, immune cells.
Measured: at 12 months
Link with intestinal adaptation
Changes in biological markers of adaptation in relation to sarcopenia: ApoB48, citrulline, leptin, nutrients
Measured: at 12 months
Quantification of intestinal adsorption and its link with intestinal adaptation
Changes in intestinal absorption balance markers of adaptation in relation to sarcopenia: digestive losses in fat, proteins, carbohydrates and total energy. These elements will be quantified by biological assessements.
Measured: at 12 months
Link with intestinal adaptation
Changes in bacterial fermentation markers of adaptation in relation to sarcopenia: D-lactate, short-chain fatty acids (SCFAs)
Measured: at 12 months
Quantification of urinary metabolite linked with sarcopenia
Changes in urinary markers of fermentation in relation to sarcopenia (metagenomic sequencing)
Measured: at 12 months
Quantification of fecal metabolite linked with sarcopenia
Changes in fecal markers of fermentation in relation to sarcopenia (mass spectrometry)
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start18 Aug 2022
- Primary completion17 Aug 2023
- Study completion16 Jul 2024
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 Assistance Publique - Hôpitaux de ParisThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie KAPEL, MPharma PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441345
- Sponsor's protocol ID
- APHP220496
- Acronym
- SARCO-SGC
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2022
- Last updated
- 19 Nov 2024
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis
- ClinicalTrials.gov ID
- NCT05441345
- Acronym / sponsor ID
- SARCO-SGC / APHP220496
- Conditions
- Short Bowel Syndrome
- Keywords
- Sarcopenia, short bowel syndrome, adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 1 Jul 2022 (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.
Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS.
Detailed description
Patients with short bowel syndrome (SBS) will be screened and included in longitudinal or cross-sectional studies if eligible.
The longitudinal study will follow patients with type 1 SBS (enterostomy) before and every 3 months after continuity surgery for 1 year. Cross-sectional studies will follow patients with type 2 or 3 SBS (jejunocolonic or -ileal anastomosis) for 1 year (every 3 months during the first 2 years after continuity surgery or every 6 months after).
Study visits will include clinical examination, nutritional assessment, endoscopy with biopsies and/or intestinal absorption assessment planned as part of routine follow-up. In addition, questionnaires will be completed (GPAQ, SarQoL, EQ-5D -3L, SF36), with collection of stool (for routine and research) and urine samples (for research).
The objective are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS. The results may identify metabolic or microbial biomarkers and predictors of nutritional optimisation in SBS, which is a complex and costly orphan disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBS patients | – | Other: questionnaires with collection of stool and urine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in CMS cared for and followed in the gastroenterology and nutritional assistance department of Beaujon Hospital
Key inclusion criteria (3 listed)
- Age ≥18 years old
- SBS diagnosis validated by small bowel length and either type 1 (enterostomy), type 2 or 3 (jejuno-colic or -ileal anastomosis)
- Patient not objecting to the collection of personal data as part of the study
Key exclusion criteria (4 listed)
- Pregnancy
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 |
|---|---|---|
| questionnaires with collection of stool and urinequestionnaires will be completed (GPAQ, SarQoL, EQ-5D-3L, SF36), with collection of stool (for care and research) and urine | Other | SBS patients |
Primary outcome
Evolution of sarcopenia
Time frame: at 12 months
Changes in muscle strength (Jamar's dynamometer)
Evolution of sarcopenia
Time frame: at 12 months
Changes in muscle mass (bioimpedance analysis)
10 secondary outcomes
Impact of sarcopenia
Time frame: at 12 months
Impact of sarcopenia
Time frame: at 12 months
Impact of sarcopenia
Time frame: at 12 months
Impact of sarcopenia
Time frame: at 12 months
Link with intestinal adaptation
Time frame: at 12 months
Link with intestinal adaptation
Time frame: at 12 months
Quantification of intestinal adsorption and its link with intestinal adaptation
Time frame: at 12 months
Link with intestinal adaptation
Time frame: at 12 months
Quantification of urinary metabolite linked with sarcopenia
Time frame: at 12 months
Quantification of fecal metabolite linked with sarcopenia
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nathalie KAPEL, MPharma PhD principal investigator
APHP
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 Assistance Publique - Hôpitaux de Paris 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 4 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: finished, as of the sponsor's last update on 19 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of sarcopenia (time frame: at 12 months). The study lists 2 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 19 Nov 2024.