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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00003548 |
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Date of registration:
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17/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Exclusive nutritional therapy and intestinal homeostasis in pediatric inflammatory bowel disease
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Scientific title:
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Exclusive nutritional therapy and intestinal homeostasis in pediatric inflammatory bowel disease |
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Date of first enrolment:
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20/02/2012 |
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Target sample size:
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20 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00003548 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Tobias
Schwerd |
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Address:
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Lindwurmstr. 4
80337
München
Germany |
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Telephone:
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+4989 5160 7975 oder 2811 (Pforte) |
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Email:
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tobias.schwerd@med.lmu.de |
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Affiliation:
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Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie |
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Name:
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Tobias
Schwerd |
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Address:
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Lindwurmstr. 4
80337
München
Germany |
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Telephone:
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+4989 5160 7975 oder 2811 (Pforte) |
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Email:
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tobias.schwerd@med.lmu.de |
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Affiliation:
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Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
20 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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K50.9
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K50.9
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Crohn disease, unspecified
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Intervention(s)
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Group 1: Non-interventional study with children and adolescents treated for six to eight weeks with exclusive enteral nutrition for induction of remission of active crohn's disease. Before initiation of therapy diagnosis is established. Venipuncture and endoscopy are part of the routine diagnostic workup. Two to six weeks after initiation of therapy the patient will be re-evaluated. Additionally, patients will be asked to provide stool samples.
Group 2: Treatment of children or adolescents with active crohn's disease with biologicals or steroids. Before initiation of therapy diagnosis is established. Venipuncture and endoscopy are part of the routine diagnostic workup. Two to six weeks after initiation of therapy the patient will be re-evaluated. Additionally, patients will be asked to provide stool samples.
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Primary Outcome(s)
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Parameters will be evaluated before and 2-6 weeks after initiation of therapy:
1. Gut microbiome composition before and during therapy (method: sequencing).
2. Mucosal inflammation on molecular and cellular level (methods: quantitative PCR, immunohistochemistry).
3. Phenotype and Function of peripheral blood mononuclear cells (methods: FACS analysis, ELISA, qPCR).
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Secondary Outcome(s)
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Clinical and laboratory remission after 2-6 weeks of therapy; methods: history and examination, disease activity score, stool and lab work for inflammatory markers;
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Source(s) of Monetary Support
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Förderprogramm Forschung und Lehre (FöFoLe)
Dekanat der Medizinischen Fakultät
der Ludwig-Maximilians-Universität München
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Ethics review
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Status: Approved
Approval date: 04/11/2011
Contact:
ethikkommission@med.uni-muenchen.de
Ethikkommission der Med. Fakultät der LMU
+49-89-440055191
ethikkommission@med.uni-muenchen.de
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