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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000041972 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | ulcerative colitis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | University of Tsukuba |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047736 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |