UMIN-CTR Clinical Trial

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

Contact us.