Trial document
DRKS00011549
Trial Description
Title
Protect thumb-sucking and nail-biting from chronic inflammatory bowel diseases?
Trial Acronym
thumb-IBD
URL of the Trial
[---]*
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.
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.
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
Secondary IDs
- [---]*
Health Condition or Problem studied
- K50 - Crohn disease [regional enteritis]
- K51 - Ulcerative colitis
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.
Characteristics
- Non-interventional
- Other
- Non-randomized controlled trial
- Open (masking not used)
- [---]*
- Other
- Prevention
- Parallel
- N/A
- N/A
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.
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.
Countries of Recruitment
- Germany
- Austria
Locations of Recruitment
- University Medical Center
- Doctor's Practice
- Medical Center
Recruitment
- Actual
- 2017/01/02
- 2050
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- no minimum age
- 40 Years
Additional Inclusion Criteria
IBD, contact to a siblings, contact to a reference person from childhood
Exclusion Criteria
None
Addresses
-
start of 1:1-Block address primary-sponsor
- CED Service GmbH
- Mr. Klaus Fitzke
- Hopfenstraße 60
- 24103 Kiel
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0431-5929573937
- 0431-5929573988
- sekretariat at kompetenznetz-ced.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- CED Service GmbH
- Ms. Dipl. Biol. Karen Schmidt
- Hopfenstraße 60
- 24103 Kiel
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0431-5929575335
- 0431-5929573988
- k.schmidt at kompetenznetz-ced.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- CED Service GmbH
- Ms. Karen Schmidt
- Hopfenstraße 60
- 24103 Kiel
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0431-5929575335
- 0431-5929573988
- k.schmidt at kompetenznetz-ced.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- German IBD Study Group
- Mr. Klaus Fitzke
- Hopfenstraße 60
- 24103 Kiel
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0431-5929575335
- 0431-5929573988
- k.fitzke at kompetenznetz-ced.de
- [---]*
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Ferring Arzneimittel GmbH
- Fabrikstraße 7
- 24103 Kiel
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact otherSupport
Status
- Recruiting complete, follow-up continuing
- 2019/06/30
Trial Publications, Results and other Documents
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