Trial document




drksid header

  DRKS00003548

Trial Description

start of 1:1-Block title

Title

Exclusive nutritional therapy and intestinal homeostasis in pediatric inflammatory bowel disease

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Exclusive enteral nutrition has a well-estabilshed role for induction of remission in active pediatric inflammatory bowel disease. Nutritional therapy is as efficacious as steroid treatment and achieves mucosal healing for optimal prevention of future relapse. However the exact mechanism of action remains unknown. The aim of this non-interventional study is to elucidate the anti-inflammatory effects of exclusive enteral nutrition on intestinal inflammation, gut microbiota and the immune system. Patients suffering from inflammation will be examined at two timepoints: before and two to six weeks after initiation of therapy. The composition of gut microbial flora will be analysed in stool samples collected during therapy. Peripheral blood and mucosal biopsies are studied for changes in the immune system. The nutritional therapy group is controlled with patients who need to be treated with steroids or biologicals.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Inflammatory bowel disease (IBD) is being recognized with increased frequency in children and adolescents. Despite recent advances in the understading of crohn's disease the precise aetiology remains elusive. Several factors contribute to the breakdown of intestinal homeostasis, including genetic factors, the host immune system, and environmental factors such as the gut microbiota.

Optimal therapeutic strategies for the chronic bowel inflammation are aimed to achieve mucosal healing. Exclusive enteral nutrition promotes mucosal healing and is an established therapy for induction of remission in pediatric active crohns disease. However, the mechanism of action of such therapy is still unclear. The aim of the study is to elucidate the regulatory properties of exclusive enteral nutrition on the interactions between the microbiota, the intestinal epithelium and the host immune system.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003548
  •   2012/02/17
  •   [---]*
  •   yes
  •   Approved
  •   411/11, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K50.9 -  Crohn's disease, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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.

  •   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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/02/20
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   20   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Changes in the immunosuppressive medication during the last three month.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie
    • Ms.  Prof. Dr. med.  Sibylle  Koletzko 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie
    • Mr.  Dr. med.  Tobias  Schwerd 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie
    • Mr.  Dr. med.  Tobias  Schwerd 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Förderprogramm Forschung und Lehre (FöFoLe) Dekanat der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
    • Bavariaring 19
    • 80336   München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/12/15
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.