Trial document





This trial has been registered retrospectively.
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  DRKS00010238

Trial Description

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Title

Pilot study to analyze uptake kinetics of synthetic environmental micro- and nanoparticles – impact of particle size on human intestinal absorption

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Trial Acronym

TGC01GCU-63224

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URL of the Trial

http://www.lgl.bayern.de/gesundheit/arbeitsplatz_umwelt/projekte_a_z/nano_part_kinetik_oral.htm

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Brief Summary in Lay Language

The project aims at analyzing the time course of intestinal uptake of synthetic micro- and nanoparticles after oral ingestion. Of particular interest are particles that are accumulated in the food chain by environmental inputs (silver) or specifically used on an industrial scale (titanium dioxide). In an experimental approach we investigate whether orally ingested nanoparticles are absorbed more efficiently from the gastrointestinal tract than microparticles of the same material. Enhanced uptake of nanoparticles could involve dysfunction of cell homeostasis and induction of adverse effects in secondary organs. To address this issue, healthy volunteers and patients with Crohn's disease will be asked to drink once an aqueous dispersion containing micro- or nanoparticles (titanium dioxide or silver) in non-toxic concentrations. After ingestion time course of intestinal particle absorption is measured by analyzing titanium or silver concentrations in blood and urine samples taken from the volunteers at different time points over 24 hours. Based on this data size-specific kinetic profiles can be calculated for each type of particle. The results are expected to improve risk assessment of synthetic micro- and nanoparticles upon oral exposure and to identify potential high-risk groups within the general population.

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Brief Summary in Scientific Language

see above

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Organizational Data

  •   DRKS00010238
  •   2016/04/01
  •   [---]*
  •   yes
  •   Approved
  •   13098, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   K50.0 -  Crohn disease of small intestine
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Interventions/Observational Groups

  •   Healthy volunteers: single oral uptake of 45 mg titanium dioxide microparticles dispersed in 50 ml demineralized water and one week after single oral uptake of 45 mg titanium dioxide nanoparticles dispersed in 50 ml demineralized water
  •   Healthy volunteers: single oral uptake of 1,75 mg silver microparticles dispersed in 50 ml demineralized water and one week after single oral uptake of 1,75 mg silver nanoparticles dispersed in 50 ml demineralized water
  •   Patients with Crohn's disease: single oral uptake of 45 mg titanium dioxide microparticles dispersed in 50 ml demineralized water and one week after single oral uptake of 45 mg titanium dioxide nanoparticles dispersed in 50 ml demineralized water
  •   Patients with Crohn's disease: single oral uptake of 1,75 mg silver microparticles dispersed in 50 ml demineralized water and one week after single oral uptake of 1,75 mg silver nanoparticles dispersed in 50 ml demineralized water
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

For determination of background levels urine is sampled 24 hours before oral intake of particles and a blood sample (7 ml) is taken. After ingestion of particles (micro/nano) blood samples (7 ml) are taken every 60 minutes over 9 hours and urine is sampled for another 24 hours. If silver particles were used a blood sample is also taken 24 hours after ingestion. Time course of intestinal particle absorption is measured by analyzing titanium or silver concentrations in blood and urine samples from healthy volunteers and patients with Crohn's disease.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Healthy volunteers: All subjects should judge themselves as healthy and should not be under medication for at least 15 days before biomonitoring. In particular volunteers should not suffer from a chronic liver or renal disease that might influence metabolism and excretion of particles.
Patients: clinical evidence for Crohn's disease with affection of small intestine, no comorbidities of liver and kidneys.

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Exclusion Criteria

Individuals with anemia and pregnant women are excluded from the study.

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Addresses

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    • Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
    • 81925  München
    • Germany
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    • Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
    • Mr.  Prof. Dr.  Hermann  Fromme 
    • Pfarrstraße 3
    • 80538  München
    • Germany
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    • Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
    • Mr.  PD Dr.  Wolfgang  Schober 
    • Pfarrstraße 3
    • 80538  München
    • Germany
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Sources of Monetary or Material Support

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    • Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
    • 91058  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
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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.