UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025577
Receipt number R000029435
Scientific Title Development of a simple mucosal barrier evaluation method for GERD and FGIDs
Date of disclosure of the study information 2017/01/16
Last modified on 2020/01/14 08:45:07

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Basic information

Public title

Development of a simple mucosal barrier evaluation method for GERD and FGIDs

Acronym

Evaluation of mucosal barrier function in GERD and FGIDs

Scientific Title

Development of a simple mucosal barrier evaluation method for GERD and FGIDs

Scientific Title:Acronym

Evaluation of mucosal barrier function in GERD and FGIDs

Region

Japan


Condition

Condition

Gastroesophageal reflux disease, functional gastrointestinal disorders

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of gastrointestinal mucosal admittance/susceptance index

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gastrointestinal mucosal admittance/susceptance index in gastrointestinal disorders and healthy subjects

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Gastrointestinal mucosal conductance measurement under endoscopy

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

No symptomatic control
GERD
FD
IBS

Key exclusion criteria

1. Patients taking medicine (acid suppressants and prokinetics) more than 2 weeks
2. Patients who have alarm signs (vomiting, gastrointestinal bleeding etc.)

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Hiroto
Middle name
Last name Miwa

Organization

Hyogo College of Medicine

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code

663-8501

Address

1-1 Mukogawa-cho, Nisinomiya, Hyogo

TEL

0798-45-6665

Email

miwahgi@hyo-med.ac.jp


Public contact

Name of contact person

1st name Tadayuki
Middle name
Last name Oshima

Organization

Hyogo College of Medicine

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code

663-8501

Address

1-1 Mukogawa-cho, Nisinomiya, Hyogo

TEL

0798-45-6665

Homepage URL


Email

t-oshima@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology, Department of Internal Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hyogo College of Medicine

Address

1-1 Mukogawa-cho Nishinomiya Hyogo Japan

Tel

0798-45-6111

Email

rinnri@hyo-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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 16 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

20

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

2016 Year 11 Month 15 Day

Date of IRB

2016 Year 11 Month 15 Day

Anticipated trial start date

2017 Year 01 Month 16 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 08 Day

Last modified on

2020 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029435


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name