Trial document




This trial has been registered retrospectively.
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  DRKS00004553

Trial Description

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Title

A randomised, double-blind, placebo-controlled study of oral immunotherapy in peanut allergic children

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Trial Acronym

Peanut OIT

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URL of the Trial

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Brief Summary in Lay Language

1-2% of the pediatric population suffers from peanut allergy. In allergic individuals ingestion of small amounts of peanut may lead to severe and potentially life-threatening allergic reactions. There is no current curative therapy. Thus patients have to avoid peanuts very strictly, most of the times all life-long. In the recent past it could be shown that oral immunotherapy seems to be a potential curative approach for peanut allergy. Within the current study peanut-allergic children will be recruited and randomized by chance into two groups. The treatment group receives a chocolat dessert with roasted peanut, the placebo group receives a peanut-free chocolat dessert. Patients have to ingest small increasing amounts of the peanut preparation on a daily basis until they reach a maintenance dose of approximately one peanut. The purpose of this study is to induce a tolerance towards peanuts in the peanut-allergic children and thus to develop a new treatment for peanut allergy.

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Brief Summary in Scientific Language

1-2% of the pediatric population suffers from peanut allergy. In allergic individuals ingestion of small amounts of peanut may lead to severe and potentially life-threatening allergic reactions. There is no current curative therapy. Thus patients have to avoid peanuts very strictly, most of the times all life-long. In the recent past it could be shown that oral immunotherapy seems to be a potential curative approach for peanut allergy. With this kind of therapy children receive incremental doses of peanut on a daily basis orally.For this trial, children with peanut allergy will be recruited and randomized 1:1 into either of two groups (treatment group with roasted peanuts or a placebo group; for blinding a chocolate based dessert matrix as a vehicle will be used).
The purpose of this study is to induce a clinical oral desensitization/ tolerance to peanuts in children with IgE-mediated peanut allergy using oral immunotherapy. We will compare the number of patients in both groups, who tolerate a protective dose of 500mg whole peanut (approximately 1 peanut) or more at final challenge after the study. Additionally changes concerning intra-individual threshold-levels will be measured and compared in both groups. Moreover, immunological mechanisms involved in tolerance development as well as a changes in quality of life will be evaluated.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004553
  •   2013/07/31
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  •   yes
  •   Approved
  •   EA2/075/08, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   T78.1 -  Other adverse food reactions, not elsewhere classified
  •   T78.0 -  Anaphylactic shock due to adverse food reaction
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Interventions/Observational Groups

  •   At study entry all patients undergo an oral food challenge to peanut. Children of the Verum-group receive samll amounts of a chocolate dessert with peanut flour of roasted peanuts on a daily basis. Initially, a build-up phase is performed for a maximum of 10 months, every two weeks dose increases (quantity of the chocolate dessert) are performed up to a maximum dose of 500 mg or 1000mg of whole peanut which the patients will tolerate. After eight weeks of daily intake of this maintenance dose all children receive another oral food challenge.
  •   At study entry all patients undergo an oral food challenge to peanut. Patients of the Placebo-group receive a small dose of a chocolate dessert whithout roasted peanut on a daily basis-similar to the protocol of the Verum-group.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome will be the comparison between the number of patients in both groups (Placebo/ Verum) who tolerate 500mg of whole peanut or more at final oral challenge after the end of the study (visit 3), after finished oral immunotherapy/Placebo-therapy.

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Secondary Outcome

As a secondary outcome the number of patients who will not react to the maximum dose of peanut at final challenge after the end of the study (visit 3) will be compared in both groups (Placebo/ Verum).
Furthermore changes in threshold levels between baseline (visit 1, prior to oral immunotherapy) and final oral peanut challenge (visit 3, post oral immunotherapy) of patients receiving Verum/ Placebo therapy will be compared intraindividually as well as between these two groups.
Total number of objective allergic adverse events per total oral immunotherapy-doses will be compared in patients of the Verum and the placebo group (V1 to V3). In addition the total number of allergic adverse events requiring medical intervention per total oral immunotherapy-doses will be compared in patients of the Verum and the placebo group.
Changes in quality of life and burden of treatment, which will be assessed in all children and their mothers before and after completion of the study (4-5 weeks after visit 3) using the FAQLQ-CF, FAQLQ-TF, FAQLQ-PF- questionnaires and BOT-CF, BOT-TF, BOT-PF- questionnaires respectively, will be evaluated separately and compared in both groups (Verum/Placebo).
Furthermore changes in peanut-specific T-cell and B cell responses and basophil reactivity will be measured in vitro before (visit 1) and after oral immunotherapy-study (visit 3) and both groups will be evaluated separately and compared with each other.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/12/10
  •   56
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Children with
1. a sensitization against peanut (peanut-specific IgE > 0.35 kU/l)
2. challenge-proven clinical relevant peanut allergy
3. signed informed consent by the mother and father of the child
4. mother or father being mentally as well as verbally capable of understanding the
proposed intention and intervention of the study

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Exclusion Criteria

Children with
1. ongoing treatment of another form of immunotherapy (e.g. systemic or sublingual
immunotherapy against pollen) during the study period
2. participation in another interventional study trial
3. other severe diseases (following the clinical judgement of the study physician)

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Addresses

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    • Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
    • Ms.  Dr.  Kirsten Beyer,  Katharina Blümchen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
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    • Altonaer Kinderklinik
    • Mr.  Dr.  Frank  Ahrens 
    • Bleickenallee 38
    • 22763  Hamburg
    • Germany
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    •   0049-40-88908-0
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    • Kinderklinik München, Schwabing, Klinik für Kinder-und Jugendmedizin der Technischen Universität München
    • Mr.  Dr.  Armin  Grübl 
    • Parzivalstr.16
    • 80804  München
    • Germany
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    •   0049-89-3068-2260
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    • St.Josef-Hospital, Klinik für Kinder-und Jugendmedizin der Ruhr Universität Bochum
    • Mr.  Prof.Dr.  Eckard  Hamelmann 
    • Alexandrinenstr.5
    • 44791  Bochum
    • Germany
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    •   0049-234-5092611
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    • Klinik für pädiatrische Pneumologie, Allergologie,Neonatologie, Medizinische Hochschule Hannover
    • Ms.  Prof. Dr.  Gesine  Hansen 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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    •   0049-511-532-9138
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    • Zentrum für Kinder-und Jugendmedizin, Universitätsklinik Freiburg
    • Ms.  Prof. Dr.  Andrea  Heinzmann 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
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    •   0049-761-27043000
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    • Klinik für Kinder-und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
    • Ms.  Dr.  Katja  Nemat 
    • Fetscherstr.74
    • 01307  Dresden
    • Germany
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    •   0049-351-458-2073
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    • Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
    • Ms.  Dr.  Katharina  Blümchen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
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    • Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
    • Ms.  Dr.  Katharina  Blümchen 
    • Augustenburgerplatz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Berliner Sparkassenstiftung Medizin
    • Bundesallee 171
    • 10715  Berlin
    • Germany
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    • Rahel Hirsch Stipendium Universitätsmedizin Berlin, Charité
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • bea, Stiftung zur Behandlung von Ernussallergien
    • Knesebeckstr.16
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/08/25
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Trial Publications, Results and other Documents

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