Bacterial translocation and alteration of the enteral microbiome in Fontan patients as risk factor for protein-losing enteropathy

• Conditions: Protein losing enteropathy in Fontan patients; Malabsorption due to intolerance, not elsewhere classified; K90.4

• Registration Number: DRKS00011094
• Lead Sponsor: niversitätsklinikum Gießen und Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-21
• Study Completion: 2018-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Fontan patients: Fontan completion at least a year ago.
Control patients: Patients having a peripheral intravenous catheters or blood is taken as part of a heart catheter procedure for closure of a atrial septal or ventricular septal defect or an electrophysiological examination.

Exclusion Criteria

Control patients: patients suffering from heart failure or a complex heart defect

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Correlation between protein losing enteropathy disease activity score and biomarkers for intestine integrity (I-FABP) in Fontan patients with and without protein losing enteropathy.<br><br>2) Correlation between protein losing enteropathy disease activity score and biomarkers for bacterial translocation (endoCab, LBP, PGN) in Fontan patients with and without protein losing enteropathy.

Secondary Outcome Measures

Name	Time	Method
1) Correlation between heart failure marker (NT-pro-BNP) and biomarkers for intestine integrity (I-FABP) or bacterial translocation (endoCab, LBP, PGN) in Fontan patients.<br><br>2) Comparison of biomarker concentrations for intestine integrity (I-FABP) or bacterial translocation (endoCab, LBP, PGN) between Fontan patients (with and without protein losing enteropathy) and control patients.