Exclusive nutritional therapy and intestinal homeostasis in pediatric inflammatory bowel disease

• Conditions: K50.9; Crohn disease, unspecified

• Registration Number: DRKS00003548
• Lead Sponsor: Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-17
• Study Completion: 2015-12-15
• Results First Posted: 2016-03-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients suffering from active inflammatory bowel disease and need to be treated with exclusive enteral nutrition therapy, steroids or biologicals;
- Diagnosis confirmed by Porto diagnostic criteria;
- informed consent of patients (> 12 years of age) and parents.

Exclusion Criteria

Changes in the immunosuppressive medication during the last three month.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parameters will be evaluated before and 2-6 weeks after initiation of therapy:<br>1. Gut microbiome composition before and during therapy (method: sequencing).<br>2. Mucosal inflammation on molecular and cellular level (methods: quantitative PCR, immunohistochemistry).<br>3. Phenotype and Function of peripheral blood mononuclear cells (methods: FACS analysis, ELISA, qPCR).

Secondary Outcome Measures

Name	Time	Method
Clinical and laboratory remission after 2-6 weeks of therapy; methods: history and examination, disease activity score, stool and lab work for inflammatory markers; <br><br>