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RecruitingNCT07422792Updated Feb 20, 2026

Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients

An interventional study of Intravenous Amino Acids in Chronic Intestinal Failure, Intestinal Failure and Home Parenteral Nutrition, sponsored by Institute of Oncology Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Intestinal Failure
  • Intestinal Failure
  • Home Parenteral Nutrition

Keywords

  • Parenteral Nutrition
  • Intravenous Amino Acids
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

- Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intravenous Amino Acid Administration

    Patients with chronic intestinal failure receiving home parenteral nutrition receive intravenous amino acid administration for assessment of anabolic response and metabolic phenotype.

    Drug: Intravenous Amino Acids

Interventions

  • DrugIntravenous Amino Acids

    Intravenous amino acid administration to assess anabolic response and protein kinetics in patients with chronic intestinal failure receiving home parenteral nutrition

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day)

06

Study locations

1 of 1 sites recruiting
  • Institute of Oncology Ljubljana
    Ljubljana, 1000, Slovenia
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07422792
Lead sponsor
Institute of Oncology Ljubljana
Responsible party
Sponsor
First posted
Feb 20, 2026
Start date
Apr 1, 2022
Primary completion
Mar 31, 2024
Completion
Dec 31, 2027 (estimated)
Last update
Feb 20, 2026

Study contacts

Klavdija Korošec
Contact
kkorosec@onko-i.si
+386 31630065
Neža Gros
Contact
ngros@onko-i.si

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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