UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037537 |
|---|---|
| Receipt number | R000042800 |
| Scientific Title | Effect of dietary fiber intake on enteric bacteria of patients with inflammatory bowel disease and irritable bowel syndrome. |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2025/02/05 17:14:47 |
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Basic information
Public title
Effect of dietary fiber intake on enteric bacteria of patients with inflammatory bowel disease and irritable bowel syndrome.
Acronym
Effect of dietary fiber ingestion on enteric bacteria.
Scientific Title
Effect of dietary fiber intake on enteric bacteria of patients with inflammatory bowel disease and irritable bowel syndrome.
Scientific Title:Acronym
Effect of dietary fiber ingestion on enteric bacteria.
Region
| Japan |
Condition
Condition
Healthy adult, and patients with inflammatory bowel disease and irritable bowel syndrome.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the influence of water-soluble dietary fiber intake on intestinal flora and intestinal disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel-flora alteration
Key secondary outcomes
Serum chemistry, clinical manifestation, and colonoscopy at0,2,4 and 6 month after investigation.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of water-soluble dietary fiber (continuous, up to 6 month)
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) Japanese male and female volunteers (20 to 80 years old)
2) Healthy volunteer
3) Patents with inflammatory bowel disease and irritable bowel syndrome.
4) Who has received sufficient explanation about the contents and purpose of the study by the document, and has the ability to understand the informed consent with voluntary participation.
Key exclusion criteria
1) Who does not give consent.
2) Who is difficult to collect feces
3) Wo has blood contamination in stool.
4) Who is judged that systemic symptom is bad.
5) Who is in breast-feeding or pregnancy, or wishes to become pregnant during the study period.
6) Who has obstruction or stenosis of the gastrointestinal tract, or those prone to gastrointestinal obstruction.
7) Who have been ill in the past due to the ingestion of water-soluble dietary fiber.
8) Who is poor-self-determination ability, dementia, etc.
9) Who is judged as ineligible by principal investigators or researchers.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokushima University
Division name
Faculty of Pharmacy
Zip code
770-8505
Address
1-78-1 Sho-machi, Tokushima
TEL
088-633-7250
tsuchiya@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokushima University
Division name
Faculty of Pharmacy
Zip code
770-8505
Address
1-78-1 Sho-machi, Tokushima
TEL
088-633-7250
Homepage URL
tsuchiya@tokushima-u.ac.jp
Sponsor or person
Institute
Watanabe Hsopital
Institute
Department
Personal name
Funding Source
Organization
Foundation of the Seturou-Fujii Memorial Osaka Vasic Medical Research Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima, Tokushima Japan
Tel
088-633-9294
awachiken@tokushima-u.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
医療法人ミネルワ会渡辺病院（愛媛県） Watanabe Hsopital（Ehime Pref.）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042800
