Prospective study of microbiome-host interactions in pediatric inflammatory bowel disease

Recruiting

• Conditions: K50; K51; K52; Crohn disease [regional enteritis]; Ulcerative colitis; Other noninfective gastroenteritis and colitis

• Registration Number: DRKS00013306
• Lead Sponsor: Abteilung für pädiatrische Gastroenterologie und HepatologieDr. von Haunersches Kinderspital Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with suspicion of IBD or established IBD who receive treatment with exclusive enteral nutrition, steroids, aminosalicylates, immunosuppressive medications (e.g. azathioprine, methotrexate), antibiotics or biologics.

Exclusion Criteria

Patients without confirmed IBD after full diagnostic work-up will be excluded from the study.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prospective analysis of microbial signatures and their functional role for immuneregulation, treatment and clinical course of pediatric IBD patients over two years. <br>

Secondary Outcome Measures

Name	Time	Method
Prospective study with 2 years follow-up: <br><br>- Analysis of environmental factors (nutrition and life-style) for microbiom composition and function in pediatric IBD.<br>- Analysis of interactions between host genetics and microbiome.<br>- Indentification of biomarkers for personalized treatments of pediatric IBD.<br>- Long-term development of microbiom-targeting treatments in pediatric IBD.