UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008499 |
|---|---|
| Receipt number | R000009990 |
| Scientific Title | Bloody stools in children and adolescents - Role of Klebsiella oxytoca as a cause of bloody diarrhea |
| Date of disclosure of the study information | 2012/07/23 |
| Last modified on | 2018/02/06 00:23:48 |
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Basic information
Public title
Bloody stools in children and adolescents - Role of Klebsiella oxytoca as a cause of bloody diarrhea
Acronym
Bloody stools in children
Scientific Title
Bloody stools in children and adolescents - Role of Klebsiella oxytoca as a cause of bloody diarrhea
Scientific Title:Acronym
Bloody stools in children
Region
| Europe |
Condition
Condition
Bloody stools in children
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In children bloody stools are and clinical alarm-symptom. We first described antibiotic-associated hemorrhagic colitis (AAHC) caused by K. oxytoca in adults. In children the significance of this disease in children remains unclear. We propose an Austrian multicenter case-finding study to analyze the occurrence and significance of AAHC in children.
Children with bloody stools will be prospectively tested for K. oxytoca in addition to routine diagnostic workup at 7 participating Austrian pediatric hospitals. Colitis will be verified by sonography. To verify AAHC, all K. oxytoca isolates will be tested for toxin production by a Hep2-cell toxin assay established by our group. Detailed clinical data will be collected on site at the participating hospitals.
This study will answer questions about the significance, occurrence, age distribution, triggering antibiotics and presentation of AAHC caused by K. oxytoca in children.
Basic objectives2
Others
Basic objectives -Others
Causes of bloody diarrhea in children
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Causes of bloody stools in children
Key secondary outcomes
K. oxytoca as a cause of bloody diarrhea in children
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
bloody stools/diarrhea
Key exclusion criteria
>18 years old
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Karl Martin Hoffmann |
Organization
Medical University Graz, Austria
Division name
Division of General Pediatrics, Department of Pediatrics and Adolescent Medicine
Zip code
Address
Auenbruggerplatz 30, A-8036 Graz, Austria
TEL
031638512605
hoffmaka@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Karl Martin Hoffmann |
Organization
Medical University Graz, Austria
Division name
Division of General Pediatrics, Department of Pediatrics and Adolescent Medicine
Zip code
Address
Auenbruggerplatz 34
TEL
031512605
Homepage URL
karl.hoffmann@medunigraz.at
Sponsor or person
Institute
Medical University Graz
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Medical University Graz, Austria
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
In children bloody stools are and clinical alarm-symptom. We first described antibiotic-associated hemorrhagic colitis (AAHC) caused by K. oxytoca in adults. In children the significance of this disease in children remains unclear. We propose an Austrian multicenter case-finding study to analyze the occurrence and significance of AAHC in children.
Children with bloody stools will be prospectively tested for K. oxytoca in addition to routine diagnostic workup at 7 participating Austrian pediatric hospitals. Colitis will be verified by sonography. To verify AAHC, all K. oxytoca isolates will be tested for toxin production by a Hep2-cell toxin assay established by our group. Detailed clinical data will be collected on site at the participating hospitals.
This study will answer questions about the significance, occurrence, age distribution, triggering antibiotics and presentation of AAHC caused by K. oxytoca in children.
Management information
Registered date
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009990
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
