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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046664
Receipt No. R000053232
Scientific Title Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Date of disclosure of the study information 2022/01/17
Last modified on 2022/01/17

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Basic information
Public title Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Acronym Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis
Scientific Title Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Scientific Title:Acronym Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigated whether nutritional guidance to promote zinc intake and a Japanese diet (high in n-3 fatty acids) could induce clinical remission in patients with mild active ulcerative colitis (UC).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint was clinical remission at 24 weeks.
Key secondary outcomes Secondary endpoints were the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores, the clinical activity index (CAI) evaluated based on symptoms, and biomarkers, including the zinc levels, at 12 and 24 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 nutritional guidance (intervention group)
Interventions/Control_2 control group
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
15 years-old <=
Age-upper limit
99 years-old >
Gender Male and Female
Key inclusion criteria Patients had mild active UC (patients with a UCEIS score of 2-4 points, CAI score of 5-6 points, and a distribution of the UCEIS and CAI scores at admission indicating that the patient was not in remission) were enrolled in the study.
Key exclusion criteria Patients undergoing colonoscopy without pretreatment; those with difficulty following nutritional guidance; those with an intestinal obstruction, fistula, history of colorectal surgery, moderate to severe active-phase UC, diverticulitis, or massive colorectal bleeding; and those with anemia or other underlying conditions except UC were excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshikazu
Middle name
Last name Tsuzuki
Organization Saitama medical university
Division name Department of Gastroenterology
Zip code 350-0451
Address Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
TEL +81-49-276-1667
Email ytsuzuki38@gmail.com

Public contact
Name of contact person
1st name Kazuya
Middle name
Last name Miyaguchi
Organization Saitama Medical University
Division name Department of Gastroenterology
Zip code 350-0451
Address Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
TEL +81-49-276-1667
Homepage URL
Email kaz.hr77@gmail.com

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama medical university IRB Committee
Address Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
Tel +81492761667
Email hirb@saitama-med.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 17 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 20
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
2018 Year 12 Month 13 Day
Date of IRB
2019 Year 02 Month 04 Day
Anticipated trial start date
2019 Year 02 Month 04 Day
Last follow-up date
2021 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 17 Day
Last modified on
2022 Year 01 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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