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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name