Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients

NCT07422792 | Recruiting

• 2 other identifiers: OI-707-CIF-20220120-131/2022/6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Intestinal Failure; Intestinal Failure; Home Parenteral Nutrition

Keywords

Parenteral Nutrition; Intravenous Amino Acids

Outcome Measures

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.

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

Study Arms (1)

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.

Drug: Intravenous Amino Acids

Interventions

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

Intravenous Amino Acid Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Intestinal Failure; Hyperphagia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Klavdija Korošec

CONTACT

+386 31630065; kkorosec@onko-i.si

Neža Gros

CONTACT

ngros@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group study assessing anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure receiving home parenteral nutrition.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2022
• Primary Completion: March 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)