Chronic Intestinal FailureNCT07422792
Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients
A study testing Intravenous Amino Acids in people with Chronic Intestinal Failure and Intestinal Failure, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Intestinal Failure, Intestinal Failure, Home Parenteral Nutrition
- What is being tested?
- Intravenous Amino Acids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Apr 2022to 31 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neža Gros contact
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, +386 31630065, kkorosec@onko-i.si
Neža Gros, ngros@onko-i.si
About this study
Official title: Anabolic Response To Protein And Assessment Of Metabolic Phenotype In Patients With Home Parenteral Nutrition And Chronic Intestinal Failure
The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Based on collected data on protein kinetics, the study aims to further refine and personalize nutritional mixtures in patients with CIF. Additional aims include assessment of short-chain fatty acid metabolism and evaluation of gut microbiota function in patients with CIF.
Read the detailed description
This prospective cohort study evaluates anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure (CIF) receiving home parenteral nutrition. The study aims to improve therapy of CIF patients by providing new insights into metabolism and anabolic response. Protein kinetics will be assessed to better define protein requirements and to support optimization and personalization of parenteral nutrition mixtures. The study will also assess short-chain fatty acid metabolism and provide insight into gut microbiota function in CIF patients.
- Being tested
- Intravenous Amino Acids
- Keywords
- Parenteral Nutrition, Intravenous Amino Acids
- Medical subject headings
- Intestinal Failure, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Amino AcidsDrug
Intravenous amino acid administration to assess anabolic response and protein kinetics in patients with chronic intestinal failure receiving home parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Amino Acid Administration | Experimental | Patients with chronic intestinal failure receiving home parenteral nutrition receive intravenous amino acid administration for assessment of anabolic response and metabolic phenotype. Receives: Drug: Intravenous Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion
Protein anabolic response will be assessed by whole-body protein kinetics using a stable isotope tracer methodology during intravenous amino acid administration. The outcome will be reported as the change in whole-body protein synthesis rate (µmol/kg/h) from baseline to post-infusion.
Measured: Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Apr 2022
- Primary completion31 Mar 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Intestinal FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group study assessing anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure receiving home parenteral nutrition.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422792
- Sponsor's protocol ID
- OI-707-CIF-2022
- Other IDs
- 0120-131/2022/6
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 20 Feb 2026
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Response To Protein And Assessment Of Metabolic Phenotype In Patients With Home Parenteral Nutrition And Chronic Intestinal Failure
- ClinicalTrials.gov ID
- NCT07422792
- Acronym / sponsor ID
- OI-707-CIF-2022
- Keywords
- Parenteral Nutrition, Intravenous Amino Acids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 2026 (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 purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Based on collected data on protein kinetics, the study aims to further refine and personalize nutritional mixtures in patients with CIF. Additional aims include assessment of short-chain fatty acid metabolism and evaluation of gut microbiota function in patients with CIF.
Detailed description
This prospective cohort study evaluates anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure (CIF) receiving home parenteral nutrition. The study aims to improve therapy of CIF patients by providing new insights into metabolism and anabolic response. Protein kinetics will be assessed to better define protein requirements and to support optimization and personalization of parenteral nutrition mixtures. The study will also assess short-chain fatty acid metabolism and provide insight into gut microbiota function in CIF patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group study assessing anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure receiving home parenteral nutrition.
| Arm | Type | Receives |
|---|---|---|
| Intravenous Amino Acid Administration | Experimental | Drug: Intravenous Amino AcidsPatients with chronic intestinal failure receiving home parenteral nutrition receive intravenous amino acid administration for assessment of anabolic response and metabolic phenotype. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intravenous Amino AcidsIntravenous amino acid administration to assess anabolic response and protein kinetics in patients with chronic intestinal failure receiving home parenteral nutrition | Drug | Intravenous Amino Acid Administration |
Primary outcome
Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion
Time frame: Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day)
Protein anabolic response will be assessed by whole-body protein kinetics using a stable isotope tracer methodology during intravenous amino acid administration. The outcome will be reported as the change in whole-body protein synthesis rate (µmol/kg/h) from baseline to post-infusion.
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 20 Feb 2026.
- 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.
Neža Gros contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Amino Acids in people with Chronic Intestinal Failure and Intestinal Failure, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 1 inclusion and 0 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 20 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 Slovenia. 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 Klavdija Korošec (+386 31630065, kkorosec@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion (time frame: Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day)). 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 20 Feb 2026.