UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Acronym	Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Scientific Title	Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Scientific Title:Acronym	Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Region	Japan

Condition
Condition	Inflammatory bowel disease
Classification by specialty	Gastroenterology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establish a bioresource to search biomarkers that reflect disease activity from saliva of patients with inflammatory bowel disease.
Basic objectives2	Others
Basic objectives -Others	In this study, saliva samples from patients with inflammatory bowel disease will be collected in order to establish a bioresource for the discovery of biomarkers that reflect the disease activity of inflammatory bowel disease patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will search biomarkers in saliva that reflect the disease activity of inflammatory bowel disease and analyze the results of periodontal examinations to evaluate the relationship between salivary biomarkers and the disease activity of inflammatory bowel disease.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing endoscopy at the Department of Gastroenterology, Tohoku University Hospital for the diagnosis of inflammatory bowel diseases including ulcerative colitis or Crohn's disease.
Key exclusion criteria	Patients who have a stoma, or have a medical or mental abnormality that makes it difficult to comply with protocol, or doctor decides inappropriate.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Saito
Organization	Tohoku University Graduate School of Dentistry
Division name	Department of Operative Dentistry
Zip code	989-8575
Address	4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL	022-717-8340
Email	masahiro.saito.c5@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Yahata
Organization	Tohoku University Graduate School of Dentistry
Division name	Department of Operative Dentistry
Zip code	989-8575
Address	4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL	022-717-8340
Homepage URL
Email	masahiro.saito.c5@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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	Tohoku University ethics committee
Address	4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
Tel	022-728-4105
Email	den-syom@grp.tohoku.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	2024 Year 04 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	2021 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 01 Day
Last follow-up date	2026 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, saliva will be collected as an observational study, along with periodontal histology, radiography, and intraoral photographs of the subjects.

Management information
Registered date	2021 Year 11 Month 12 Day
Last modified on	2021 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052543