Trial document




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  DRKS00011549

Trial Description

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Title

Protect thumb-sucking and nail-biting from chronic inflammatory bowel diseases?

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Trial Acronym

thumb-IBD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The reasons for the origin of a chronic inflammatory disease (IBD) are very varied and are often unsettled in particular cases.
In a new study from New Zealand it was proved, that thumb-sucking and nail-biting in the infancy leads for a reduction of the risk of e.g. asthma and hay fever. Nevertheless, a possible risk reduction for an IBD was not examined.
It is sure: both behaviour patterns raise the biodiversity of bacteria of the flora of the mouth. Hence, it seems possible, that thumb-sucking and
nail-biting raise also the variety of the childish intestinal flora and thereby decrease the risk for the origin of an IBD.

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Brief Summary in Scientific Language

Thumb-sucking and nail-biting raise the proof likelyhood from enterobacteriaceae and intestinal parasite in the mouth. Hence, it seems possible that thumb-sucking and nail-biting also raise the variety of childish intestinal microbiome. Topically it was proved first that thumb-sucking and nail-biting in the infancy leads to a reduction of the risk of an atopic sensitization at the adult's age (Lynch et Al.:Pediatrics in 2016).
Hence, it is interesting to examine first in a case control study, whether thumb-sucking
and nail-biting protect also against IBD.

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Organizational Data

  •   DRKS00011549
  •   2017/01/04
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   4922-09/16/16, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K50 -  Crohn disease [regional enteritis]
  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   IBD patients < 40 years are questioned by a 4 page questionnaire about the hygienic conditions, thumb-suckings, nail-biting, breast-feeding etc. in the childhood to different times.
  •   Siblings of IBD patients without IBD are questioned by a questionnaire about the hygienic conditions, thumb-suckings, nail-biting, breast-feeding etc. in the childhood to different times.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Relation between thumb-sucking or nail-biting in the pre-school age and/or at the young adult's age and the reduction of IBD risk. The data are raised by a patient's questionnaire.

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Secondary Outcome

Relation between hygiene-related risk factors of IBD (use of disinfectants, animal contact, breast-feeding) and the reduction of IBD risk. The data are raised by a patient's questionnaire.

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/01/02
  •   2050
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   40   Years
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Additional Inclusion Criteria

IBD, contact to a siblings, contact to a reference person from childhood

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Exclusion Criteria

None

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Addresses

  • start of 1:1-Block address primary-sponsor
    • CED Service GmbH
    • Mr.  Klaus  Fitzke 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    • CED Service GmbH
    • Ms.  Dipl. Biol.  Karen  Schmidt 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • CED Service GmbH
    • Ms.  Karen  Schmidt 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • German IBD Study Group
    • Mr.  Klaus  Fitzke 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    • Ferring Arzneimittel GmbH
    • Fabrikstraße 7
    • 24103  Kiel
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   2019/06/30
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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.