UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044047
Receipt number R000050113
Scientific Title Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse
Date of disclosure of the study information 2021/05/07
Last modified on 2021/04/26 14:50:33

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Basic information

Public title

Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse

Acronym

Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse

Scientific Title

Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse

Scientific Title:Acronym

Prospective observational study of stool metagenome and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse

Region

Japan


Condition

Condition

inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Perform stool metagenomic and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse

Basic objectives2

Others

Basic objectives -Others

Perform stool metagenomic and metabolome analysis of patients with inflammatory bowel disease aiming to develop IBD omics score for the predict of relapse

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analysis of omics data of IBD patients in remission: Use metagenomic analysis, metabolome analysis, and transcriptome analysis at enrollment

Key secondary outcomes

The development of IBD omics score for predict of relapse: Examine IBD patients who maintained remission by 52 weeks and IBD patients who relapsed within 52 weeks using metagenomic analysis, metabolome analysis, and transcriptome analysis.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients in clinical remission(Crohn's disease: maintain Harvey-Bradshaw index 3 or less for 3 months or more. Ulcerative colitis: Maintain Partial Mayo 1 and less for 3 months or more.
Patients 16 years and over at the time of consent acquisition
Patients who voluntarily consented in writing after receiving sufficient explanation for participation in this study

Key exclusion criteria

Patients with unconfirmed diagnosis
Patients receiving steroids
Patients taking antithrombotic drugs
Patients who do not consent to this study
Patients judged to be ineligible by the research director

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Nakase

Organization

Sapporo Medical University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

060-8543

Address

South 1 West 16, Chuo-ku, Sapporo, Japan

TEL

011-611-2111

Email

hiropynakase@gmail.com


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Wagasuma

Organization

Sapporo Medical University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

060-8543

Address

South 1 West 16, Chuo-ku, Sapporo, Japan

TEL

011-611-2111

Homepage URL


Email

k.wagatsuma@sapmed.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Clinical Research Section, Research Support Section, Secretariat, Sapporo Medical University

Address

South 1 West 17, Chuo-ku, Sapporo, Japan

Tel

011-611-2111

Email

ji-rskk@sapmed.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

札幌医科大学医学部 消化器内科学講座(北海道)


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 07 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 06 Day

Date of IRB

2020 Year 09 Month 10 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

(1): Collection of patient clinical data
(2): Metagenomic analysis and metabolome analysis of micobiota by feces at the enrollment. If possible, add oral bacterial flora analysis
(3): Transcriptome analysis at the enrollment using colon tissue by biopsy at colonoscopy.
(4): Analyze the omics data at the enrollment based on the information obtained in (1) to (3).
(5): From the time of enrollment, follow-up is performed every 4 to 12 weeks (+/- 2 weeks) for up to 52 weeks (+/- 8 weeks) to evaluate remission or relapse.
(6): Perform metagenomic analysis and metabolome analysis by feces of patients with remission / relapse. If possible, perform transcriptome analysis using colon tissue by biopsy at colonoscopy. Collect these data to develop a IBD omics score for the predict of relapse.


Management information

Registered date

2021 Year 04 Month 26 Day

Last modified on

2021 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050113


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name