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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008499
Receipt No. 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

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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
Email 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
Email karl.hoffmann@medunigraz.at

Sponsor
Institute Medical University Graz
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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