UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053629 |
|---|---|
| Receipt number | R000061205 |
| Scientific Title | Microbiome Improvement by Hangeshashinto in diarrhea-type irritable bowel syndrome: MI-HAN study |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/02/15 23:16:49 |
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Basic information
Public title
Microbiome Improvement by Hangeshashinto in diarrhea-type irritable bowel syndrome: MI-HAN study
Acronym
Microbiome Improvement by Hangeshashinto in diarrhea-type irritable bowel syndrome: MI-HAN study
Scientific Title
Microbiome Improvement by Hangeshashinto in diarrhea-type irritable bowel syndrome: MI-HAN study
Scientific Title:Acronym
Microbiome Improvement by Hangeshashinto in diarrhea-type irritable bowel syndrome: MI-HAN study
Region
| Japan |
Condition
Condition
diarrhea-type irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyzed the changes in microbiota using Hangeshashinto in patients with diarrhear-type irritable bowel disease (IBS-D) and the efficacy of it in a multicenter observational study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of Hangeshashinto to IBS-D
Key secondary outcomes
The changes of microbiome by Hangeshashinto
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients diagnosed with IBS-D based on the ROME IV criteria
Key exclusion criteria
Patients with IBD, serious fatal disease, and those taking other herbal medicines
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
6060856
Address
Kajii-cho 465 Kamigyo-ku, Kyoto, Japan
TEL
+85-75-251-5519
naohisa@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural Univedrsity of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku, Kyoto, Japan
TEL
0752515519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tsumura
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kyoto prefectural univeristy of medicine
Address
Kajii-cho 465, Kamigyo-ku, Kyoto, Japan
Tel
+81-752515337
rinri@koto.kpu-m.ac.jp
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
| 2024 | Year | 02 | Month | 15 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 05 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 15 | Day |
Other
Other related information
The inistitution of case enrollement
1. Nishijin Hospital
2. Nara City Hospital
3. Ayabe City Hospital
4. Aiseikai Yamashina Hospital
Management information
Registered date
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061205
