UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029969 |
|---|---|
| Receipt number | R000033915 |
| Scientific Title | A single arm study of efficay of bifidobacterium for chronic constipation |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2021/08/30 12:45:04 |
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Basic information
Public title
A single arm study of efficay of bifidobacterium for chronic constipation
Acronym
A feasile study of efficay of bifidobacterium for chronic constipation
Scientific Title
A single arm study of efficay of bifidobacterium for chronic constipation
Scientific Title:Acronym
A feasile study of efficay of bifidobacterium for chronic constipation
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of bifidobacterium for chronic constipation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in JPAC-QOL score from pre-to after 8 weeks intervention
Key secondary outcomes
1,The comparison of JPAC-QOL score between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention and at 2 weeks after drug intervention(end of study)
2,The comparison of stool form,degree of sense of incomplete evacuation,degree of straining and frequency of internal use of rescue drugs between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention and at 2 weeks after drug intervention(end of study)
3, The change in profile of gut microbiome from pre-to after 8 weeks drug intervention
4,The drug compliance
5,The incidence rate of adverse events
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
bifidobacterium
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
1, Patients who are diagnosed chronic constipation by ROME criteria
2, Patients who can exhibit their consent in a document
Key exclusion criteria
1, Patients who have bristol score 1 or 7
2, Patients who have fewer than one defecation per week
3, Patients who have obvious defecation disorders
4, Patients who have fewer than one of overall JPAC-QOL score
5, Patients who are excluded mechanical disorders by colonoscopy within five years
6, Patients who have severe complications
7, Patients who have history or current evidence of celiac disease or inflammatory bowel disease
8, Patients who are under treatment with steroid or biological products
9, Patients who have severe psychiatric disease
10, Patients who have current evidence of abuse of drugs or alcohol
11, Patients who have history of bifidobacteria allergies
12, Patients who had taken new drug therapy within 4 weeks before entry
13, Patients who had any change in types, dosage,or adiministration of their prescribed drugs within 4 weeks before entry
14, Patients who or are going to take new medicines
15, Patients who or are going to be participating in other clinical studies
16, Patients who are under treatment with other probiotics
17, Patients who are judged as inadequately for study entry
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuyuki Akiko |
Organization
Yokohama City University school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
Homepage URL
fuyuki-sin@umin.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Biofermin Pharmacutical 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
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
| 2017 | Year | 11 | 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
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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033915
