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Recruiting NCT07422792

Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients

No phase Interventional Chronic Intestinal Failure Intestinal Failure Home Parenteral Nutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Amino Acids.
Who it may be relevant to
Registry conditions: Chronic Intestinal Failure, Intestinal Failure, Home Parenteral Nutrition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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)]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Slovenia · 1 center
  • Institute of Oncology Ljubljana — Ljubljana

Identifiers

NCT: NCT07422792 · OI-707-CIF-2022 · 0120-131/2022/6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗