UMIN-CTR Clinical Trial

Basic information
Public title	A study of the efficacy of glutamine and prebiotics in the patients with inflammatory bowel disease
Acronym	Efficacy of glutamine and prebiotics in the patients with inflammatory bowel disease
Scientific Title	A study of the efficacy of glutamine and prebiotics in the patients with inflammatory bowel disease
Scientific Title:Acronym	Efficacy of glutamine and prebiotics in the patients with inflammatory bowel disease
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of efficacy of enteral supplementation product enriched with glutamine, dietary fiber, and oligosaccharide (GFO) in patients with ulcerative colitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of intestinal inflammation
Key secondary outcomes	Circulating levels of GLP-2 and incretins

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Each subject will take GFO 3packs/day, thrice daily with meal for 30 days.
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with ulcerative colotis 2) Patients who can gave written consents by herself or himself
Key exclusion criteria	1) Patients who have severe hepatic or renal disease 2) Patients whose conditions of ulcerative colitis are unstable 3) Patients who have history of gastrectomy or extensive enterectomy 4) Patients who have malignant tumor under treatment 5) Patients who are judged as not appropriate for participation
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuya Inagaki
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
Zip code
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Akihiro Hamasaki
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
Zip code
Address
TEL	075-751-3560
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterology and Hepatology, Department of Diabetes and Clinical Nutrition Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Kyoto 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
Address
Tel
Email

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	2010 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	Preinitiation
Date of protocol fixation	2010 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 01 Day
Last modified on	2010 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005162

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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