UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040872 |
|---|---|
| Receipt number | R000046670 |
| Scientific Title | Effects of MIYA-BM for clinical symptoms and gut microbiome in patients with chronic constipation. |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2024/04/20 09:56:00 |
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Basic information
Public title
Effects of MIYA-BM for clinical symptoms and gut microbiome in patients with chronic constipation.
Acronym
Effects of MIYA-BM for clinical symptoms and gut microbiome in patients with chronic constipation.
Scientific Title
Effects of MIYA-BM for clinical symptoms and gut microbiome in patients with chronic constipation.
Scientific Title:Acronym
Effects of MIYA-BM for clinical symptoms and gut microbiome in patients with chronic constipation.
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore unknown possibilities of probiotics for the treatment of chronic constipation, evaluating the clinical efficacy of MIYA-BM and its effects for gut microbiome in patients with chronic constipation.
Basic objectives2
Others
Basic objectives -Others
Probiotics is proposed to be used as one of the useful treatments for chronic constipation in the Japanese Guideline for the Management of Chronic Constipation. The aim of this study is to explore unknown possibilities of probiotics for the treatment of chronic constipation, evaluating the clinical efficacy of MIYA-BM and its effects for gut microbiome in patients with chronic constipation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptomatic improvement of chronic constipation evaluated with Constipation Scoring System
Key secondary outcomes
1,Improvement of constipation specific quality of life evaluated with Japanese version of Patient Assessment of Quality of Life questionnaire (JPAC-QOL)
2,The comparison of bowel movement
3,The comparison of stool consistency
4,The comparison of gut microbiome
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
1, Patients who visited our department, seeking for treatment of constipation.
2, The score of Constipation Scoring System (0: no symptoms - 30: worst symptoms) is 5 or over.
3, Patients who can promise that they do not start or increase the dosage of medication for chronic constipation while they take MIYA-BM for 28-35 days in this study.
Key exclusion criteria
1, Patients who took MIYA-BM within one month before entering this study.
2, Pregnant or lactating woman.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Mimura |
Organization
Jichi Medical University
Division name
Division of Gastroenterological, General and Transplant Surgery, Department of Surgery
Zip code
329-0498
Address
3311-1 Yakushiji Shimotsuke-shi,Tochigi
TEL
0285-58-7371
mimurat@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Homma |
Organization
Jichi Medical University
Division name
Division of Gastroenterological, General and Transplant Surgery, Department of Surgery
Zip code
329-0498
Address
3311-1 Yakushiji Shimotsuke-shi,Tochigi
TEL
0285-58-7371
Homepage URL
y.homma@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Division of Gastroenterological, General and Transplant Surgery, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
MIYARISAN PHARMACEUTICAL CO. LTD.
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
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji Shimotsuke-shi,Tochigi
Tel
0285587371
rinri@jichi.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
自治医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
The subjects are patients who visited our department, seeking for treatment of constipation. Their constipation symptoms and gut microbiome are to be compared before and after taking MIYA-BM for 4-5 weeks.
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046670
| Research Plan | |
|---|---|
| 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 |
