UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020685
Receipt No. R000023866
Scientific Title Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Date of disclosure of the study information 2016/02/01
Last modified on 2018/07/24

* 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 Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Acronym Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Scientific Title Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Scientific Title:Acronym Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate whether or not the effect of nutrition therapy on microbiota could contribute to long-term clinical outcome of ulcerative colitis patients with mucosal healing prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The effect of nutrition therapy on microbiota
Key secondary outcomes 1.The involvement of microbiota after nutrition therapy in clinical outcome of patients with ulceartive colitis after achieving mucosal healing.
2.The involvement of the change of diet in transition of microbiota

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 nutrition counselling: For patients with ulcerative colitis, a questionnaire survey of diet will be performed. Four weeks after first survey, second survey will be performed for evaluating the effect of nutrition counselling. We will evaluate the microbiota with T-RFLP analysis at 1st and 2nd survey.
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
16 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Ulcerative colitis patient with complete remission
2. Patient without treament with antibiotics one month before participating this clinical study
3. Patient without infectious enterocolitis
Key exclusion criteria 1. Pregnant woman or woman with possibility of pregnancy
2. Patient who were impossible to perform colonoscopy
3. Patient with malignancy
4. Patient with stoma
5. Patient with a history of intestinal resection for three months
6. Patient who were unsuitable for this study by physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Yoshino
Organization Kitano Hospital
Division name Digestive Disease Center
Zip code
Address 2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL 06-6312-1221
Email t-yoshino@kitano-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Yoshino
Organization Kitano Hospital
Division name Digestive Disease Center
Zip code
Address 2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL 06-6312-1221
Homepage URL
Email t-yoshino@kitano-hp.or.jp

Sponsor
Institute Kitano Hospital
Institute
Department

Funding Source
Organization Kitano Hospital
Organization
Division
Category of Funding Organization Other
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
2016 Year 02 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 Completed
Date of protocol fixation
2016 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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
2016 Year 01 Month 21 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.