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NCT Number: NCT07422792

Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients

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.

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Key information

Conditions

Chronic Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Home Parenteral Nutrition Hyperphagia Intestinal Diseases Intestinal Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Intravenous amino acids

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Klavdija Korošec

CONTACT

[email protected]

+386 31630065

Neža Gros

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Anabolic Response To Protein And Assessment Of Metabolic Phenotype In Patients With Home Parenteral Nutrition And Chronic Intestinal Failure

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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