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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011094

Enrollment

200

Registered

2016-09-21

Start date

2017-03-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein losing enteropathy in Fontan patients K90.4

Interventions

Group 1: Collection of blood and stool samples, examination of clinical parameters as well as echocardiography from Fontan patients without protein losing enteropathy Group 2: Collection of blood and

Eligibility

Sex/Gender

All

Age

No minimum to 30 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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

Measure	Time frame
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. 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.	—

Countries

Germany, Netherlands

Contacts

Public ContactMarkus;Floris E.A. Khalil;Udink ten Cate

Universitätsklinikum Giessen. Abteilung für Kinderkardiologie;Amalia Children's Hospital, Radboud University Medical Center

Markus.Khalil@paediat.med.uni-giessen.de;Floris.UdinktenCate@radboudumc.nl0641/985-43461;+31243614430

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026