Short Bowel SyndromeNCT07206004
Effect of Parenteral Support on FibroScan in Short Bowel Syndrome
An observational study of Short Bowel Syndrome and Intestinal Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Home Parenteral Support (HPS) is a life-sustaining treatment for patients with short bowel syndrome and intestinal failure. This study aims to investigate how administration of parenteral support affects FibroScan results in order to determine optimal timing of liver assessment in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome, Intestinal Failure, Liver Diseases
- What is being tested?
- Fibroscan
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2026to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with short bowel syndrome receiving regular PS
Who may be able to join
- Adult patients (≥18 years) with short bowel syndrome with capacity to give consent
- Patients receiving regular PS (≥4 days/week and ≥10 liters/week)
- Stable clinical condition
Who cannot join
- Known liver cirrhosis
- Active infection, severe dehydration, or electrolyte disturbances
- Pregnancy
- Receiving IV fluids or medications on study day
- Tapered infusion rate prior to disconnection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Digestive Diseases, Transplantation and General Surgery, Rigshospitalet
Copenhagen, Capital Region, 2100
Jessica R Wentworth, MD, +4521212254, Jessica.jennifer.ramsing.wentworth@regionh.dk
About this study
Official title: Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients With Short Bowel Syndrome
Home Parenteral Support (HPS) is a life-sustaining treatment for patients with short bowel syndrome and intestinal failure. This study aims to investigate how administration of parenteral support affects FibroScan results in order to determine optimal timing of liver assessment in this patient population.
Read the detailed description
The objective of this study is to investigate the applicability and accuracy of FibroScan in assessing liver status among patients with short bowel syndrome and intestinal failure, both before and after administration of PS, by assessing the immediate effect of PS administration on FibroScan results in patients with short bowel syndrome. This is of particular importance since the timing of FibroScan relative to PS administration and infusion volume is presumed to influence the results, and thereby potentially the interpretation of hepatic status.By understanding how parenteral support influences FibroScan measurements, we aim to optimize the use of this non-invasive technique for monitoring liver status in patients with intestinal failure, thereby defining the optimal timing of scanning in relation to PS administration. This could potentially enable earlier detection of hepatic complications and thereby improve the long-term prognosis for these patients.
Once included, participants must fast and abstain from fluids for 3 hours prior to the examination. Measurements will consist of a FibroScan, blood pressure, body weight, and bioimpedance analysis.
Measurements will be performed:
- Immediately before initiation of PS
- Two hours after initiation of PS
- Immediately after disconnection of PS
- Two hours after completion of PS Participants will collect urine from 0 to 14 hours. Spot urine sodium will be analyzed at 0 hours and 14 hours. Urine volume will be measured and then discarded. The standard infusion time for PS is set at 12 hours overnight.
- Conditions
- Short Bowel Syndrome, Intestinal Failure, Liver Diseases
- Being tested
- Fibroscan
- Keywords
- FibroScan, transient elastography, parenteral nutrition, intestinal failure, hepatic fibrosis
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure, Liver Diseases, Hyperphagia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDiagnostic test
Fibroscan will be perfomed while the patient receives their usual parenteral support
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort - patients with short bowel syndrome on parenteral support | Patients will receive their ususal parenteral support during the study Receives: Diagnostic Test: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroscran
Change in transient elastography (FibroScan) values before, during, and after parenteral support
Measured: 14 hours
Secondary outcomes (3)
CAP score
Change in CAP score before, during, and after PS
Measured: 14 hours
Correlation of Fibroscan and PS
Correlation of changes in FibroScan values with PS composition and volume
Measured: 14 hours
Correlation of Fibroscan and other factors
Correlation with body weight, blood pressure, body fluid content, and urine output
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 Copenhagen University Hospital, RigshospitaletThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ramsing Wentworth, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rahim M Naimi, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206004
- Sponsor's protocol ID
- H-25037724
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pironi L, Sasdelli AS. Intestinal Failure-Associated Liver Disease. Clin Liver Dis. 2019 May;23(2):279-291. doi: 10.1016/j.cld.2018.12.009. Epub 2019 Feb 21.
PubMed 30947877de Ledinghen V, Vergniol J. Transient elastography (FibroScan). Gastroenterol Clin Biol. 2008 Sep;32(6 Suppl 1):58-67. doi: 10.1016/S0399-8320(08)73994-0.
PubMed 18973847Gu C, Wang H, Shu J, Zheng J, Li D, Cai C, Zhang P. RNA sequencing combining with whole exome sequencing reveals a compound heterozygous variant in ATM in a girl with atypical ataxia-telangiectasia. Clin Chim Acta. 2021 Dec;523:6-9. doi: 10.1016/j.cca.2021.08.026. Epub 2021 Aug 25.
PubMed 34453918Lee J, Lee R, Erpelding T, Siddoway RL, Gao J. The effect of water intake on ultrasound tissue characteristics and hemodynamics of adult livers. Clin Exp Hepatol. 2021 Jun;7(2):223-230. doi: 10.5114/ceh.2021.107068. Epub 2021 Jun 30.
PubMed 34295991Silva M, Costa Moreira P, Peixoto A, Santos AL, Lopes S, Goncalves R, Pereira P, Cardoso H, Macedo G. Effect of Meal Ingestion on Liver Stiffness and Controlled Attenuation Parameter. GE Port J Gastroenterol. 2019 Mar;26(2):99-104. doi: 10.1159/000488505. Epub 2018 Apr 20.
PubMed 30976614Alvarez D, Orozco F, Mella JM, Anders M, Antinucci F, Mastai R. Meal ingestion markedly increases liver stiffness suggesting the need for liver stiffness determination in fasting conditions. Gastroenterol Hepatol. 2015 Aug-Sep;38(7):431-5. doi: 10.1016/j.gastrohep.2015.01.009. Epub 2015 Mar 11.
PubMed 25769876Khunpakdee N, Jayanama K, Kaewdoung P, Promson K, Rattanasiri S, Warodomwichit D, Kantachuvesiri S, Sobhonslidsuk A. Transient Elastography in End-Stage Renal Disease Patients on Hemodialysis: The Effect of Net Fluid Withdrawal. Blood Purif. 2015;40(3):256-9. doi: 10.1159/000439582. Epub 2015 Oct 3.
PubMed 26430774Millonig G, Friedrich S, Adolf S, Fonouni H, Golriz M, Mehrabi A, Stiefel P, Poschl G, Buchler MW, Seitz HK, Mueller S. Liver stiffness is directly influenced by central venous pressure. J Hepatol. 2010 Feb;52(2):206-10. doi: 10.1016/j.jhep.2009.11.018. Epub 2009 Dec 4.
PubMed 20022130
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07206004
- Acronym / sponsor ID
- H-25037724
- Conditions
- Short Bowel Syndrome, Intestinal Failure, Liver Diseases
- Keywords
- FibroScan, transient elastography, parenteral nutrition, intestinal failure, hepatic fibrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Oct 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.
Home Parenteral Support (HPS) is a life-sustaining treatment for patients with short bowel syndrome and intestinal failure. This study aims to investigate how administration of parenteral support affects FibroScan results in order to determine optimal timing of liver assessment in this patient population.
Detailed description
The objective of this study is to investigate the applicability and accuracy of FibroScan in assessing liver status among patients with short bowel syndrome and intestinal failure, both before and after administration of PS, by assessing the immediate effect of PS administration on FibroScan results in patients with short bowel syndrome. This is of particular importance since the timing of FibroScan relative to PS administration and infusion volume is presumed to influence the results, and thereby potentially the interpretation of hepatic status.By understanding how parenteral support influences FibroScan measurements, we aim to optimize the use of this non-invasive technique for monitoring liver status in patients with intestinal failure, thereby defining the optimal timing of scanning in relation to PS administration. This could potentially enable earlier detection of hepatic complications and thereby improve the long-term prognosis for these patients.
Once included, participants must fast and abstain from fluids for 3 hours prior to the examination. Measurements will consist of a FibroScan, blood pressure, body weight, and bioimpedance analysis.
Measurements will be performed:
- Immediately before initiation of PS
- Two hours after initiation of PS
- Immediately after disconnection of PS
- Two hours after completion of PS Participants will collect urine from 0 to 14 hours. Spot urine sodium will be analyzed at 0 hours and 14 hours. Urine volume will be measured and then discarded. The standard infusion time for PS is set at 12 hours overnight.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort - patients with short bowel syndrome on parenteral support | – | Diagnostic Test: FibroscanPatients will receive their ususal parenteral support during the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with short bowel syndrome receiving regular PS
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) with short bowel syndrome with capacity to give consent
- Patients receiving regular PS (≥4 days/week and ≥10 liters/week)
- Stable clinical condition
Key exclusion criteria (5 listed)
- Known liver cirrhosis
- Active infection, severe dehydration, or electrolyte disturbances
- Pregnancy
- Receiving IV fluids or medications on study day
- Tapered infusion rate prior to disconnection
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 |
|---|---|---|
| FibroscanFibroscan will be perfomed while the patient receives their usual parenteral support | Diagnostic test | Observational Cohort - patients with short bowel syndrome on parenteral support |
Primary outcome
Fibroscran
Time frame: 14 hours
Change in transient elastography (FibroScan) values before, during, and after parenteral support
3 secondary outcomes
CAP score
Time frame: 14 hours
Correlation of Fibroscan and PS
Time frame: 14 hours
Correlation of Fibroscan and other factors
Time frame: 14 hours
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 3 Oct 2025.
- Background: PubMed 30947877Pironi L, Sasdelli AS. Intestinal Failure-Associated Liver Disease. Clin Liver Dis. 2019 May;23(2):279-291. doi: 10.1016/j.cld.2018.12.009. Epub 2019 Feb 21.
- Background: PubMed 18973847de Ledinghen V, Vergniol J. Transient elastography (FibroScan). Gastroenterol Clin Biol. 2008 Sep;32(6 Suppl 1):58-67. doi: 10.1016/S0399-8320(08)73994-0.
- Background: PubMed 34453918Gu C, Wang H, Shu J, Zheng J, Li D, Cai C, Zhang P. RNA sequencing combining with whole exome sequencing reveals a compound heterozygous variant in ATM in a girl with atypical ataxia-telangiectasia. Clin Chim Acta. 2021 Dec;523:6-9. doi: 10.1016/j.cca.2021.08.026. Epub 2021 Aug 25.
- Background: PubMed 34295991Lee J, Lee R, Erpelding T, Siddoway RL, Gao J. The effect of water intake on ultrasound tissue characteristics and hemodynamics of adult livers. Clin Exp Hepatol. 2021 Jun;7(2):223-230. doi: 10.5114/ceh.2021.107068. Epub 2021 Jun 30.
- Background: PubMed 30976614Silva M, Costa Moreira P, Peixoto A, Santos AL, Lopes S, Goncalves R, Pereira P, Cardoso H, Macedo G. Effect of Meal Ingestion on Liver Stiffness and Controlled Attenuation Parameter. GE Port J Gastroenterol. 2019 Mar;26(2):99-104. doi: 10.1159/000488505. Epub 2018 Apr 20.
- Background: PubMed 25769876Alvarez D, Orozco F, Mella JM, Anders M, Antinucci F, Mastai R. Meal ingestion markedly increases liver stiffness suggesting the need for liver stiffness determination in fasting conditions. Gastroenterol Hepatol. 2015 Aug-Sep;38(7):431-5. doi: 10.1016/j.gastrohep.2015.01.009. Epub 2015 Mar 11.
- Background: PubMed 26430774Khunpakdee N, Jayanama K, Kaewdoung P, Promson K, Rattanasiri S, Warodomwichit D, Kantachuvesiri S, Sobhonslidsuk A. Transient Elastography in End-Stage Renal Disease Patients on Hemodialysis: The Effect of Net Fluid Withdrawal. Blood Purif. 2015;40(3):256-9. doi: 10.1159/000439582. Epub 2015 Oct 3.
- Background: PubMed 20022130Millonig G, Friedrich S, Adolf S, Fonouni H, Golriz M, Mehrabi A, Stiefel P, Poschl G, Buchler MW, Seitz HK, Mueller S. Liver stiffness is directly influenced by central venous pressure. J Hepatol. 2010 Feb;52(2):206-10. doi: 10.1016/j.jhep.2009.11.018. Epub 2009 Dec 4.
- 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.
Rahim M Naimi, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 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 3 Oct 2025. 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 Denmark. 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 Jessica R Wentworth, MD (+4521212254, Jessica.jennifer.ramsing.wentworth@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroscran (time frame: 14 hours). 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 NCT07206004, which also lists 8 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 3 Oct 2025.