UMIN-CTR Clinical Trial

Basic information
Public title	Impact of sleep disturbance on functional gastrointestinal disorders
Acronym	Functional GI disorders and sleep disturbance
Scientific Title	Impact of sleep disturbance on functional gastrointestinal disorders
Scientific Title:Acronym	Functional GI disorders and sleep disturbance
Region	Japan

Condition
Condition	Functional GI disorders
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify impact of sleep disturbance on functional GI disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of symptoms of functional GI disorders after 4 week administration of sleep medicine
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with functional GI disorder who have symptoms 2) Patients who have sleep disturbance and who3) Patients who are able to sign a consent form
Key exclusion criteria	1) Patients who received surgery of GI tract 2) Patients who take sleep medicine 3) Patients whom prescriptions except sleep medicine will be changed 4) Patients who are not suitable for the study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8137
Email	shikokuri@gunma-u.ac.jp

Public contact
Name of contact person	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8137
Homepage URL
Email	shikokuri@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	MSD K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gunma University Hospital
Address	3-39-15 Showa-machi, Maebashi, Gunma
Tel	027-220-8137
Email	shikokuri@gunma-u.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	2018 Year 04 Month 23 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/33602148/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/33602148/
Number of participants that the trial has enrolled	15
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	2018 Year 03 Month 12 Day
Date of IRB	2018 Year 03 Month 29 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate improvement of GI symptoms using questionnaires after 4 week administration of sleep medicine

Management information
Registered date	2018 Year 04 Month 17 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036688