UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021411 |
|---|---|
| Receipt number | R000024696 |
| Scientific Title | clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/09/10 20:51:04 |
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Basic information
Public title
clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Acronym
clinical efficacy of oral administration of metronidazole in the treatment of PSC
Scientific Title
clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Scientific Title:Acronym
clinical efficacy of oral administration of metronidazole in the treatment of PSC
Region
| Japan |
Condition
Condition
primary sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the efficacy and the safety of oral administration of metronidazole for 12 weeks during the administration period and subsequent 12 weeks following the cessation. Furthermore, We examine the interaction of gut microbiota and immune cells during the treatment, aiming to clarify the pathogenesis of PSC via gut-liver axis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Serological improvement in the hepatobiliary function (serum ALP and total bilirubin) at 12weeks after the treatment
Key secondary outcomes
Alteration of the intestinal flora during the treatment
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
Patients take metronidazole 250mg orally three times day for 3 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with a chronic cholestasis who are diagnosed as PSC with the specific findings by MRCP or ERCP
2. Patients with chronic liver injury or compensated liver cirrhosis (Child Pugh score below 9 point)
3. Presence or absence of the PSC-related colitis does not matter for an entry
4. Patients elder than 16 years old who are consented in writing of the applicant
Key exclusion criteria
Patients with a decompensated cirrhosis (Child Pugh score upper 10 point)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Nakamoto |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Nakamoto |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
nobuhiro@z2.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024696
