UMIN-CTR Clinical Trial

Public title

Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders

Acronym

Autonomic function analysis by using wearable device in FGIDs

Scientific Title

Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders

Scientific Title:Acronym

Autonomic function analysis by using wearable device in FGIDs

Region

Japan

Condition

Functional dyspepsia, Irritable bowel syndrome

Classification by specialty

Medicine in general	Hepato-biliary-pancreatic medicine	Psychosomatic Internal Medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the pathophysiology of functional gastrointestinal disorders by the analysis of the relationship between autonomic nervous system function and gastrointestinal symptoms.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change amounts of autonomic nervous system function during the presence of clinical symptoms

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with functional gastrointestinal disorders who meet criteria for Rome IV

Key exclusion criteria

Subjects who have the history of gastrointestinal operation
Subjects who have pacemaker and implantable cardioverter defibrillator
Subjects who is considered as ineligible by the physician

Target sample size

90

Name of lead principal investigator

1st name	Fumio
Middle name
Last name	Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Gastroenterology

Zip code

5458585

Address

1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka

TEL

06-6645-3811

Email

m2079981@med.osaka-cu.ac.jp

Name of contact person

1st name	Fumio
Middle name
Last name	Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Gastroenterology

Zip code

5458585

Address

1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka

TEL

06-6645-3811

Homepage URL

Email

m2079981@med.osaka-cu.ac.jp

Institute

Osaka City University

Institute

Department

Personal name

Organization

Wellness Open Living Lab. LLC

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka City University Review Board

Address

1-2-7, Asahimachi, Abeno-ku, Osaka city, Osaka

Tel

06-6646-6125

Email

ethics@med.osaka-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

14

Day

URL releasing protocol

PLoS One. 2022 Dec 9;17(12):e0278922. doi: 10.1371/journal.pone.0278922.

Publication of results

Published

URL related to results and publications

PLoS One. 2022 Dec 9;17(12):e0278922. doi: 10.1371/journal.pone.0278922.

Number of participants that the trial has enrolled

90

Results

In patients with IBS, sympathetic nerve activity was activated 2 min before defecation, which was correlated with abdominal symptoms and lower QOL.

Results date posted

2023

Year

01

Month

17

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This was a prospective multicenter study in which patients with IBS visiting Osaka City University and Osaka Medical and Pharmaceutical University participated between July 2018 and May 2019.

Participant flow

This was a prospective multicenter study in which patients with IBS visiting Osaka City University and Osaka Medical and Pharmaceutical University participated between July 2018 and May 2019.

Adverse events

None

Outcome measures

The main outcome was changes in the autonomic nervous function before and after defecation, which were compared between the control and IBS groups. Other measured values of autonomic nervous function were compared as secondary outcomes. Furthermore, correlations between the measured values of autonomic nervous function, symptom scores, and QOL scores were evaluated.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2017

Year

06

Month

16

Day

Date of IRB

2017

Year

10

Month

04

Day

Anticipated trial start date

2017

Year

07

Month

14

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We obtain biological information such as autonomic nervous system function by wearing device for 24 hours. We also obtain the information about gastrointestinal symptoms, defecation, and sleep by using the application software on the smartphone.

Registered date

2017

Year

07

Month

14

Day

Last modified on

2023

Year

01

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032325