UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021397
Receipt number R000024679
Scientific Title Evaluation of Duodenal Mucosal Admittance Index in Patients with Functional Dyspepsia (FD)
Date of disclosure of the study information 2016/03/31
Last modified on 2019/03/16 16:01:42

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Basic information

Public title

Evaluation of Duodenal Mucosal Admittance Index in Patients with Functional Dyspepsia (FD)

Acronym

Evaluation of Duodenal Mucosal Admittance Index in Patients with Functional Dyspepsia (FD)

Scientific Title

Evaluation of Duodenal Mucosal Admittance Index in Patients with Functional Dyspepsia (FD)

Scientific Title:Acronym

Evaluation of Duodenal Mucosal Admittance Index in Patients with Functional Dyspepsia (FD)

Region

Japan


Condition

Condition

Functional dyspepsia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of duodenal mucosal admittance index in FD patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Duodenal mucosal admittance index of FD patients 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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Tissue Conductance Meter

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 who are diagnosed functional dyspepsia by Rome III criteria.
2. Patients who are older than 20 years old.
3. Patients from whom written informed consent is obtained.

Key exclusion criteria

1.Patients who have a history of pacemaker or ICD implantation.
2. Patients who have a history of electrical device implantation to brain such as deep brain stimulation.
3. Patients whose conditions are likely to cause upper abdominal symptoms such as malignant tumors, peptic ulcers, and systemic diseases (neurological diseases including Parkinson's disease, metabolic diseases including diabetes, etc.).
4. Patients with predominant GERD.
5. Patients who are suspicious for IBS.
6. Patients who have a history of upper gastrointestinal tract operation.
7. Patients who have a history of brain structural disease including schizophrenia, and depression.
8. Patients who have severe disorder of cardiovascular, liver or renal function, infection, and hematopoietic organ.
9. Patients who are taking aspirin, NSAIDs, corticosteroids or other immunosuppressive drugs.
10. Patients whose causes of dyspepsia are considered excessive drinking, overeating, and severe stress.
11. Patients who are alcohol or drug dependent.
12. Pregnancy or lactation woman. Patients who hope pregnancy during study.
13. Patients who took H. pylori eradication therapy within 6 months.
14. Patients who are judged as being inappropriate for this study by their medical doctor.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Arai

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1, Inohana, Chuo-ku, Chib acity, Chiba prefecture, Japan

TEL

043-226-2083

Email

araim-cib@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Ishigami

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1, Inohana, Chuo-ku, Chib acity, Chiba prefecture, Japan

TEL

043-226-2083

Homepage URL


Email

ishigami-ncu@umin.ac.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Chiba University

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


Address


Tel


Email



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

2016 Year 03 Month 31 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

Completed

Date of protocol fixation

2015 Year 06 Month 30 Day

Date of IRB

2015 Year 06 Month 30 Day

Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 08 Day

Last modified on

2019 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024679


Research Plan
Registered date File name
2017/09/09 2298計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name