UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041972 |
|---|---|
| Receipt number | R000047736 |
| Scientific Title | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/10/01 22:55:13 |
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Basic information
Public title
Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis.
Acronym
BS-UC-2020
Scientific Title
Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis.
Scientific Title:Acronym
BS-UC-2020
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine if dietary intake of sulforaphane-rich broccoli sprouts improve ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal calprotectin level (before and after 8 weeks treatment)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Broccoli Sprouts (20 g/day, 8 weeks)
Interventions/Control_2
Alfalfa Sprouts (20 g/day, 8 weeks)
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. Age higher than 20 years.
2. Mild UC (Rachmilewits index less than 5)
3. Presence of maintenance therapy with mesalazine
4. Appropriate informed consent
5. Fecal Protectin level higher than upper limit of normal value
Key exclusion criteria
1. Regular use of lactobacillus, steroids, immuno-modulators, biological drugs, caclineurin inhibitors, JAK kinase inhibitors.
2. Fecal Protectin level less than upper limit of normal value
3. Hospitalized Patients
4. Start of ASA treatment, or iIncrease in 5-ASA within 4 weeks
5. G-CAP or L-CAP treatment within 3 months
6. Treatment with herbal medicine including quingdao
7. Any other reasons judged by the principle investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Yanaka |
Organization
University of Tsukuba Hospital
Division name
Hitachi Medical Education and Reserach Center
Zip code
317-0077
Address
2-1-1 Jounann-cho, Hitachi-shi, Ibaraki-ken
TEL
0294-23-1111
ynk-aki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Yanaka |
Organization
University of Tsukuba
Division name
Hitachi Medical Education and Research Center
Zip code
317-0077
Address
2-1-1, Jounan-cho, Hitachi-shi, Ibaraki-ken
TEL
0294-23-1111
Homepage URL
ynk-aki@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi General Hospital
Address
2-1-1, Jounan-cho, Hitachi-shi, Ibaraki-ken
Tel
0294-23-1111
masahiro.miura.cz@hitachi.com
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
| 2020 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047736
