UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014871 |
|---|---|
| Receipt number | R000017292 |
| Scientific Title | Capsule study on prevalence and severity of intestinal abnormality in pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces. |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2018/08/19 10:05:43 |
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Basic information
Public title
Capsule study on prevalence and severity of intestinal abnormality in pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces.
Acronym
Capsule study on prevalence of intestinal abnormality in pulmonary tuberculosis .
Scientific Title
Capsule study on prevalence and severity of intestinal abnormality in pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces.
Scientific Title:Acronym
Capsule study on prevalence of intestinal abnormality in pulmonary tuberculosis .
Region
| Japan |
Condition
Condition
Pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces.
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence and severity of intestinal abnormality in pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces by Capsule study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We can find the prevalence and severity of intestinal abnormality in pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces by Capsule study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Capsules to invastigate the intestinal lesion for the pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pulmonary tuberculosis patients with acid-fast bacilli smear-positive feces who are 20-year-old to 95-year-old.
Key exclusion criteria
Patinet who has intestinal stenosis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunao Nitsuma |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Infectious disease and pulmonary medicine
Zip code
Address
21-2Maeda, Tanisawa, Kawahigashi,Aizuwaakmatsu City Fukushima,969-3492 Japan
TEL
+81-242-75-2100
kazu1024@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saitou Miwako |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Infectious disease and pulmonary medicine
Zip code
Address
21-2Maeda, Tanisawa, Kawahigashi,Aizuwaakmatsu City Fukushima,969-3492 Japan
TEL
+81-242-75-2100
Homepage URL
aizuanes@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Aizu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University Aizu Medical Center
Organization
Division
Category of Funding Organization
Local Government
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 25 | 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
Fourteen patients underwent SBCE to the terminal ileum. Thevideowasnotrecordedforonepatientwhowasexcluded from the analysis. Intestinal lesions, including 5 annular ulcers in 4 patients, were observed in 64% .In subgroup analysis, prevalence tended to be higher in patients undergoing SBCE within 1 month of anti-tuberculous therapy (P=0.051). Distribution of small intestinal lesions tended to be distal. Four of five annular ulcers were located close to the ileocecal valve.
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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017292
| Research Plan | |
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| 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 |
