NCT06391762

Brief 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). First, the investigators aim to characterize this population and then to assess if insecurity is associated with some disease criteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

6 days

First QC Date

April 22, 2024

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Deprivation level

    Determine the deprivation level of this population using the f-EDI of each participant

    Throughout study completion, an average of 1 month

Secondary Outcomes (1)

  • Association between deprivation level and disease characteristics

    Throughout study completion, an average of 1 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Patients not living in France
  • Transitory short-bowel syndrome with a predicted bowel length \> 200cm after digestive continuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Related Publications (7)

  • Tudrej BV, Martinière A, Etonno R, et al. Scores de précarité en pratique clinique. Médecine. 2019;15(3):117-125

    BACKGROUND
  • 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.

    PMID: 35206501BACKGROUND
  • Pironi 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.

    PMID: 36796121BACKGROUND
  • Pironi 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.

    PMID: 27086884BACKGROUND
  • Pironi 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.

    PMID: 34620351BACKGROUND
  • Calvar 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.

    PMID: 36567853BACKGROUND
  • Winkler 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.

    PMID: 24418898BACKGROUND

MeSH Terms

Conditions

Short Bowel SyndromeIntestinal Failure

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 30, 2024

Study Start

December 28, 2023

Primary Completion

January 3, 2024

Study Completion

January 3, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations