UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030327 |
|---|---|
| Receipt number | R000034635 |
| Scientific Title | Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1 |
| Date of disclosure of the study information | 2017/12/22 |
| Last modified on | 2019/03/28 23:31:50 |
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Basic information
Public title
Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
Acronym
LEAC study
Scientific Title
Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
Scientific Title:Acronym
LEAC study
Region
| Japan |
Condition
Condition
Nonspecific multiple ulcers in the small intestine unrelated to NSAID (Chronic enteropathy associated with SLCO2A1: CEAS)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the lubiprostones's effect on CEAS by using double-balloon enteroscopy and probe-based confocal endomicroscopy in addition to blood, urine, and stool tests and patholgical change.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Enteroscopic improvement after lubiprotone treatment
2) Endocmicroscopic improvement of leaky gut syndrome
Key secondary outcomes
1)Serum iron, ferritin, total protein, and albumin
2) Urine PGE-MUM/Cr
3) Fecal calprotectin
4) Oter blood test data
5) Symptomatic improvement
6) Pathologic change
7) Bowel movements
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
lubiprostone(12 micrograms) for 8 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with CEAS who provide informed consent.
Key exclusion criteria
1) Contraindications of enteroscopy
2) Bad conditions such as small bowel obstruction
3) Severe cardiac or pulmonary disease
4) Allergy to lubiprostone or contraindications of lubiprostone
5) Within 1 month of another clinical trial
6) Pregnant or lactating women
7) Man or woman who does not comply with this trial
8) Inappropriate situations judged by attending doctors
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Mylan EPD G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
藤田保健衛生大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
4
Results
1. Lubiprostone should be carefully prescribed especially to patients with small bowel stenosis.
2. The enteroscopic improvement with 12 microgram of lubiprostone was limited in patietns with CEAS.
3. Electron microscopy revealed the increased volume of water between cells by administration of lubiprostone with intact tight junction.
Results date posted
| 2019 | Year | 03 | Month | 28 | Day |
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
| 2017 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034635
