Short Bowel SyndromePRECAR-SGCNCT06391762
Level of Deprivation Assessment in a Population of Short-bowel Syndrome Patients With Intestinal Failure
An observational study of Short Bowel Syndrome and Intestinal Failure, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The association between social deprivation and chronic disease is regularly examined but there are no data available on patients with intestinal failure due to short bowel syndrome (SBS-IF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome, Intestinal Failure, Deprivation, Psychosocial
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2023to 3 Jan 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
- Adult, Older adult
Study population: Patients over 18 years of age suffering from Short-bowel syndrome with intestinal failure, monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital, between March 1st 2020 and November 30th 2023
Who may be able to join
- Patients over 18 years of age
- Suffering from Short-bowel syndrome with intestinal failure
- Monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital
- Between March 1st 2020 and November 30th 2023
Who cannot join
- Patients not living in France
- Transitory short-bowel syndrome with a predicted bowel length > 200cm after digestive continuity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Level of Deprivation Assessment in the Population of Short-bowel Syndrome With Intestinal Failure Patients Monitored by the Nancy University Hospital, France, Between 2020 and 2023
The association between social deprivation and chronic disease is regularly examined but there are no data available on patients with intestinal failure due to short bowel syndrome (SBS-IF). First, the investigators aim to characterize this population and then to assess if insecurity is associated with some disease criteria.
Read the detailed description
This exploratory cross-sectional study was conducted on patients affected by intestinal failure in short bowel syndrome and monitored by the certified home parenteral nutrition (HPN) center of Nancy University Hospital.
The investigators included all patients over 18 years old suffering from SBS-IF followed-up by the certified HPN center of Nancy University Hospital between March 1st, 2020, and November 30th, 2023.
The f-EDI (a European ecological index adapted to France) was determined for each participant.
The investigators set the initial date at 2020, as this corresponds to the start of the use of patient-specific formulas in the center. Exclusion criteria were: not living in France, because it's required to use French-EDI and patients under 18 years old because they are monitored by the children's hospital. Investigators also excluded patients with transitory type 1 SBS who would have a bowel length over 2 meters after re-establishment of digestive continuity.
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Deprivation level
Determine the deprivation level of this population using the f-EDI of each participant
Measured: Throughout study completion, an average of 1 month
Secondary outcomes (1)
Association between deprivation level and disease characteristics
Determine the association between the deprivation level of the patients with SBS-IF determined by f-EDI and the characteristics of their disease
Measured: Throughout study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start28 Dec 2023
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHOT Niasha, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391762
- Sponsor's protocol ID
- 2023PI056
- Acronym
- PRECAR-SGC
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tudrej BV, Martinière A, Etonno R, et al. Scores de précarité en pratique clinique. Médecine. 2019;15(3):117-125
Merville O, Launay L, Dejardin O, Rollet Q, Bryere J, Guillaume E, Launoy G. Can an Ecological Index of Deprivation Be Used at the Country Level? The Case of the French Version of the European Deprivation Index (F-EDI). Int J Environ Res Public Health. 2022 Feb 17;19(4):2311. doi: 10.3390/ijerph19042311.
PubMed 35206501Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Muhlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN practical guideline: Home parenteral nutrition. Clin Nutr. 2023 Mar;42(3):411-430. doi: 10.1016/j.clnu.2022.12.003. Epub 2023 Jan 9.
PubMed 36796121Pironi L. Definitions of intestinal failure and the short bowel syndrome. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):173-85. doi: 10.1016/j.bpg.2016.02.011. Epub 2016 Feb 18.
PubMed 27086884Pironi L, Steiger E, Joly F, Jeppesen PB, Wanten G, Sasdelli AS, Chambrier C, Aimasso U, Mundi MS, Szczepanek K, Jukes A, Theilla M, Kunecki M, Daniels J, Serlie M, Poullenot F, Cooper SC, Rasmussen HH, Compher C, Seguy D, Crivelli A, Santarpia L, Guglielmi FW, Kozjek NR, Schneider SM, Ellegard L, Thibault R, Matras P, Matysiak K, Van Gossum A, Forbes A, Wyer N, Taus M, Virgili NM, O'Callaghan M, Chapman B, Osland E, Cuerda C, Udvarhelyi G, Jones L, Won Lee AD, Masconale L, Orlandoni P, Spaggiari C, Diez MB, Doitchinova-Simeonova M, Serralde-Zuniga AE, Olveira G, Krznaric Z, Czako L, Kekstas G, Sanz-Paris A, Jauregui MEP, Murillo AZ, Schafer E, Arends J, Suarez-Llanos JP, Youssef NN, Brillanti G, Nardi E, Lal S; Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN; European Society for Clinical Nutrition and Metabolism. Characteristics of adult patients with chronic intestinal failure due to short bowel syndrome: An international multicenter survey. Clin Nutr ESPEN. 2021 Oct;45:433-441. doi: 10.1016/j.clnesp.2021.07.004. Epub 2021 Jul 28.
PubMed 34620351Calvar E, Launay L, Boyer A, Launoy G, Lobbedez T, Chatelet V. Effects of Social Deprivation on the Proportion of Preemptive Kidney Transplantation: A Mediation Analysis. Transplant Direct. 2021 Sep 7;7(10):e750. doi: 10.1097/TXD.0000000000001203. eCollection 2021 Oct.
PubMed 36567853Winkler MF, Smith CE. Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):32S-37S. doi: 10.1177/0148607113517717. Epub 2014 Jan 13.
PubMed 24418898
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Deprivation Assessment in the Population of Short-bowel Syndrome With Intestinal Failure Patients Monitored by the Nancy University Hospital, France, Between 2020 and 2023
- ClinicalTrials.gov ID
- NCT06391762
- Acronym / sponsor ID
- PRECAR-SGC / 2023PI056
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 30 Apr 2024 (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 association between social deprivation and chronic disease is regularly examined but there are no data available on patients with intestinal failure due to short bowel syndrome (SBS-IF). First, the investigators aim to characterize this population and then to assess if insecurity is associated with some disease criteria.
Detailed description
This exploratory cross-sectional study was conducted on patients affected by intestinal failure in short bowel syndrome and monitored by the certified home parenteral nutrition (HPN) center of Nancy University Hospital.
The investigators included all patients over 18 years old suffering from SBS-IF followed-up by the certified HPN center of Nancy University Hospital between March 1st, 2020, and November 30th, 2023.
The f-EDI (a European ecological index adapted to France) was determined for each participant.
The investigators set the initial date at 2020, as this corresponds to the start of the use of patient-specific formulas in the center. Exclusion criteria were: not living in France, because it's required to use French-EDI and patients under 18 years old because they are monitored by the children's hospital. Investigators also excluded patients with transitory type 1 SBS who would have a bowel length over 2 meters after re-establishment of digestive continuity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age suffering from Short-bowel syndrome with intestinal failure, monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital, between March 1st 2020 and November 30th 2023
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Suffering from Short-bowel syndrome with intestinal failure
- Monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital
- Between March 1st 2020 and November 30th 2023
Key exclusion criteria (2 listed)
- Patients not living in France
- Transitory short-bowel syndrome with a predicted bowel length > 200cm after digestive continuity
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
Deprivation level
Time frame: Throughout study completion, an average of 1 month
Determine the deprivation level of this population using the f-EDI of each participant
1 secondary outcome
Association between deprivation level and disease characteristics
Time frame: Throughout study completion, an average of 1 month
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 30 Apr 2024.
- BackgroundTudrej BV, Martinière A, Etonno R, et al. Scores de précarité en pratique clinique. Médecine. 2019;15(3):117-125
- Background: PubMed 35206501Merville O, Launay L, Dejardin O, Rollet Q, Bryere J, Guillaume E, Launoy G. Can an Ecological Index of Deprivation Be Used at the Country Level? The Case of the French Version of the European Deprivation Index (F-EDI). Int J Environ Res Public Health. 2022 Feb 17;19(4):2311. doi: 10.3390/ijerph19042311.
- Background: PubMed 36796121Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Muhlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN practical guideline: Home parenteral nutrition. Clin Nutr. 2023 Mar;42(3):411-430. doi: 10.1016/j.clnu.2022.12.003. Epub 2023 Jan 9.
- Background: PubMed 27086884Pironi L. Definitions of intestinal failure and the short bowel syndrome. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):173-85. doi: 10.1016/j.bpg.2016.02.011. Epub 2016 Feb 18.
- Background: PubMed 34620351Pironi L, Steiger E, Joly F, Jeppesen PB, Wanten G, Sasdelli AS, Chambrier C, Aimasso U, Mundi MS, Szczepanek K, Jukes A, Theilla M, Kunecki M, Daniels J, Serlie M, Poullenot F, Cooper SC, Rasmussen HH, Compher C, Seguy D, Crivelli A, Santarpia L, Guglielmi FW, Kozjek NR, Schneider SM, Ellegard L, Thibault R, Matras P, Matysiak K, Van Gossum A, Forbes A, Wyer N, Taus M, Virgili NM, O'Callaghan M, Chapman B, Osland E, Cuerda C, Udvarhelyi G, Jones L, Won Lee AD, Masconale L, Orlandoni P, Spaggiari C, Diez MB, Doitchinova-Simeonova M, Serralde-Zuniga AE, Olveira G, Krznaric Z, Czako L, Kekstas G, Sanz-Paris A, Jauregui MEP, Murillo AZ, Schafer E, Arends J, Suarez-Llanos JP, Youssef NN, Brillanti G, Nardi E, Lal S; Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN; European Society for Clinical Nutrition and Metabolism. Characteristics of adult patients with chronic intestinal failure due to short bowel syndrome: An international multicenter survey. Clin Nutr ESPEN. 2021 Oct;45:433-441. doi: 10.1016/j.clnesp.2021.07.004. Epub 2021 Jul 28.
- Background: PubMed 36567853Calvar E, Launay L, Boyer A, Launoy G, Lobbedez T, Chatelet V. Effects of Social Deprivation on the Proportion of Preemptive Kidney Transplantation: A Mediation Analysis. Transplant Direct. 2021 Sep 7;7(10):e750. doi: 10.1097/TXD.0000000000001203. eCollection 2021 Oct.
- Background: PubMed 24418898Winkler MF, Smith CE. Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):32S-37S. doi: 10.1177/0148607113517717. Epub 2014 Jan 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Intestinal Failure, run by Central Hospital, Nancy, France 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 4 inclusion and 2 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 30 Apr 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?
Deprivation level (time frame: Throughout study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391762, which also lists 7 linked publications.
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 30 Apr 2024.