UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device
Acronym	Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device
Scientific Title	Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device
Scientific Title:Acronym	Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device
Region	Japan

Condition
Condition	functional dyspepsia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the pathophysiology by serially analyzing the association between gastrointestinal symptoms and changes in the autonomic nerve function using a wearable device.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of change in the autonomic nerve function at the time of symptom appearance (maximum rate of change in HF-LF/HF from the baseline)
Key secondary outcomes	<Autonomic nerve function> 1. Mean HF-LF/HF during 24 hours, total power (VLF+LF+HF) 2. Mean HF-LF/HF at the baseline 3. Mean HF-LF/HF at the time of symptom appearance 4. Mean HF-LF/HF before defecation to on defecation, maximum/minimum HF-LF/HF 5. Mean HF-LF/HF after defecation, maximum/minimum HF-LF/HF 6. Rate of change in HF-LF/HF before and after defecation 7. Symptom index (SI) *SI = Number of symptoms with autonomic balance abnormalities during 24 hours/total number of symptoms that appeared during 24 hours 8. Symptom sensitivity index (SSI) *SSI = Number of symptoms with autonomic balance abnormalities during 24 hours/total number of autonomic balance abnormalities during 24 hours 9. Mean HF-LF/HF during sleep 10. Mean HF-LF/HF on awakening <Gait, posture, and sleep> The association between gait/posture and gastrointestinal symptoms will be examined by analyzing bio-information, and the quality of sleep will be compared between groups. <Background factors> 1. Age, sex, body mass index (BMI) 2. Smoking, alcohol consumption 3. Presence or absence of oral drugs (acid secretion inhibitors, digestive motor function-improving drugs, 5-HT3 receptor antagonists, mucosal epithelial function-changing drugs, purgatives, antidiarrheals, Chinese herbal drugs, antidepressants, anxiolytic drugs, anticholinergic drugs) 4. Total duration of gastrointestinal symptom appearance, severity of symptoms, frequency of symptoms 5. Anxiety/depressive factors 6. Health-related quality of life (HR-QOL)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Patient group in which patients with functional dyspepsia are instructed to wear a wearable device for 1 day
Interventions/Control_2	Control group in which healthy adults are instructed to wear a wearable device for 1 day
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	A. Patients with functional gastrointestinal disorder (functional dyspepsia, irritable bowel syndrome) -Patients with functional gastrointestinal disorder meeting the Rome IV diagnostic criteria -Patients aged 20 to 79 years B. Healthy adults -Adults without gastrointestinal symptoms -Those aged 20 to 79 years
Key exclusion criteria	Those with a history of gastrointestinal surgery -Pacemaker- or implantation-type defibrillator-wearing adults -Those who are considered ineligible by the investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazuhide Middle name Last name Higuchi
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan
TEL	072-683-1221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Toshihisa Middle name Last name Takeuchi
Organization	Osaka Medical College Hospigtal
Division name	Endoscopy Center
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan
TEL	072-683-1221
Homepage URL
Email	in2097@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College, Second Department of Internal Medicine
Institute
Department

Funding Source
Organization	Osaka Medical College, Second Department of Internal Medicine
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	Osaka Medical College
Address	2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan
Tel	072-683-1221
Email	rinri@osaka-med.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	大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 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	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 18 Day
Last modified on	2019 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031860

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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