Trial document




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  DRKS00000148

Trial Description

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Title

Effect of a fructose reduced diet in children and adolescents with proven fructose malabsorption with regard to recurrent abdominal pain

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Children and adolescents with proven fructose malabsorption, detected by H2 breath tests, which have been performed because of recurrent abdominal complaints are offered to follow a fructose reduced diet over a period of 2 weeks. Previous experiences showed a significant improvement of abdominal pain and other symptoms under the diet. However, there is no controlled prospective data regarding the efficacy of a fructose restriction in these subjects.
Trial: Patients with suspicious fructose malabsorption due to their complaints and after exclusion of non-functional intestinal disease were randomised and receive either a standardised fructose restricted diet or do not. After 2 weeks intervention all patients receive a H2 breath test. Questionaires has to be filled in before and after intervention. The investigating doctor is blinded in terms of the knowledge of diet or standard food. The breath test results were then correlated with the mode of intervention (in order to exclude a placebo effect). Subjects with a positive H2 breath test and fructose malabsoption, randomised to the non-diet group will benefit from the diet two weeks later as theoretically possible. These patients were again evaluated two weeks later.

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Brief Summary in Scientific Language

Children and adolescents with proven fructose malabsorption, detected by H2 breath tests, which have been performed because of recurrent abdominal complaints are offered to follow a fructose reduced diet over a period of 2 weeks. Previous experiences showed a significant improvement of abdominal pain and other symptoms under the diet. However, there is no controlled prospective data regarding the efficacy of a fructose restriction in these subjects.
Trial: Patients with suspicious fructose malabsorption due to their complaints and after exclusion of non-functional intestinal disease were randomised and receive either a standardised fructose restricted diet or do not. After 2 weeks intervention all patients receive a H2 breath test. Questionaires has to be filled in before and after intervention. The investigating doctor is blinded in terms of the knowledge of diet or standard food. The breath test results were then correlated with the mode of intervention (in order to exclude a placebo effect). Subjects with a positive H2 breath test and fructose malabsoption, randomised to the non-diet group will benefit from the diet two weeks later as theoretically possible. These patients were again evaluated two weeks later.

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Organizational Data

  •   DRKS00000148
  •   2009/09/14
  •   [---]*
  •   yes
  •   Approved
  •   84/08, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1111-6765 
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Health Condition or Problem studied

  •   R10.4 -  Other and unspecified abdominal pain
  •   E74.3 -  Other disorders of intestinal carbohydrate absorption
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Interventions/Observational Groups

  •   1. Fructose reduced food for 2 weeks (food containing low anmounts of fructose were recommended)
  •   No special diet
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Other
  •   Parallel
  •   N/A
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Primary Outcome

1. Pain frequency
2. Pain intensity
Questionaire two weeks after inital inquiry, scale 1-10 for pains, frequency: pain episodes/week

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/09/15
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   18   Years
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Additional Inclusion Criteria

Recurrent abdominal pain over more than thrree months

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Exclusion Criteria

Non-functional intestinal disease

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Addresses

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    • Zentrum für Kinder- und Jugendmedizin, HELIOS Klinikum Wuppertal, Universität Witten-Herdecke
    • Mr.  Prof. Dr. med.  Stefan  Wirth 
    • Heusnerstr. 40
    • 42283  Wuppertal
    • Germany
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    • Zentrum für Kinder- und Jugendmedizin, HELIOS Klinikum Wuppertal
    • Mr.  Prof. Dr. med.  Stefan  Wirth 
    • Heusnerstr. 40
    • 42283  Wuppertal
    • Germany
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    •   0202-8963833
    •   [---]*
    •   [---]*
    •   [---]*
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    • Zentrum für Kinder- und Jugendmedizin, HELIOS Klinikum Wuppertal
    • Mr.  Prof. Dr. med.  Stefan  Wirth 
    • Heusnerstrt. 40
    • 42283  Wuppertal
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Klinikum Wuppertal, Universität Witten/Herdecke
    • Mr.  Sascha  John 
    • HELIOS Klinikum Wuppertal, Heusnerstr. 40
    • 42283  Wuppertal
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/08/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.