UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028463
Receipt number R000032587
Scientific Title An observation study of constipation and gut microbiota due to gastric acid suppressive drugs
Date of disclosure of the study information 2017/08/01
Last modified on 2022/08/04 09:08:16

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Basic information

Public title

An observation study of constipation and gut microbiota due to gastric acid suppressive drugs

Acronym

Study of constipation and gut microbiota due to gastric acid suppressive drugs

Scientific Title

An observation study of constipation and gut microbiota due to gastric acid suppressive drugs

Scientific Title:Acronym

Study of constipation and gut microbiota due to gastric acid suppressive drugs

Region

Japan


Condition

Condition

Constipation

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of constipation and gut microbiota due to acid suppressive drugs

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relation of constipation and gut microbiota after intake of acid suppressive drugs

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with early gastric cancer or superficial esophageal cancer who will receive PPI or PCAB for six weeks after endoscopic resection

Key exclusion criteria

Patients whom a researcher judged to be inappropriate as a subject
Patients without written informed consent
Patients with history of gastrectomy or esophagectomy
Patients with intake of acid suppressive drugs before this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Dohi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

osamu-d@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of 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

Kyoto Prefectural University of Medicine

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.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 08 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

45

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

No longer recruiting

Date of protocol fixation

2017 Year 07 Month 31 Day

Date of IRB

2017 Year 08 Month 09 Day

Anticipated trial start date

2017 Year 08 Month 10 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 09 Month 30 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

This study is aimed to evaluate relation between constipation and change of gut microbiota after intake of acid suppressive drugs.


Management information

Registered date

2017 Year 07 Month 31 Day

Last modified on

2022 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032587


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name