UMIN-CTR Clinical Trial

Basic information
Public title	Risk of inner ear involvement in patients with inflammatory bowel disease: a population-based cohort study
Acronym	inflammatory bowel disease and hearing loss/vertigo
Scientific Title	Risk of inner ear involvement in patients with inflammatory bowel disease: a population-based cohort study
Scientific Title:Acronym	inflammatory bowel disease and hearing loss/vertigo
Region	Japan

Condition
Condition	Hearing loss and balance disorders
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the relationship between inflammatory bowel disorders and hearing loss/dizziness.
Basic objectives2	Others
Basic objectives -Others	To reveal a prevalence of hearing loss/dizziness in patients with inflammatory bowel diseases.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A prevalence of hearing loss/dizziness in patients with inflammatory bowel diseases based on questionnaire-based survey.
Key secondary outcomes	Audiometric features of hearing loss in patients with inflammatory bowel diseases.

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	6 years-old <
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	All patients with ulcerative colitis/Crohn's disease who are under follow-up in Tokyo Medical and Dental University Hospital.
Key exclusion criteria	Patients who have difficulty in expressing willingness to participate in this clinical study.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Fujikawa
Organization	Tokyo Medical and Dental University
Division name	Otolaryngology
Zip code	113-8519
Address	1-5-45, Bunkyo-ku, Yushima, Tokyo, Japan
TEL	03-5308-5308
Email	fujikawa.oto@tmd.ac.jp

Public contact
Name of contact person	1st name Taro Middle name Last name Fujikawa
Organization	Tokyo Medical and Dental University
Division name	Otolaryngology
Zip code	113-8519
Address	1-5-45, Bunkyo-ku, Yushima, Tokyo, Japan
TEL	03-5308-5308
Homepage URL
Email	fujikawa.oto@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental 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	Tokyo Medical and Dental University Hospital of Medicine, Clinical Research Center
Address	1-5-45, Bunkyo-ku, Yushima, Tokyo, Japan
Tel	03-5308-5612
Email	tiken.crc@tmd.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	東京医科歯科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 21 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	500
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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 08 Day
Date of IRB	2020 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 10 Month 12 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry	2022 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	622 patients were registered. Audiometry was performed for 421 patients.

Management information
Registered date	2021 Year 01 Month 21 Day
Last modified on	2022 Year 01 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049178