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 | 2025/02/04 09:16:16 |
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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
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
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
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
not releasing
Publication of results
Unpublished
Result
URL related to results and publications
not releasing
Number of participants that the trial has enrolled
45
Results
in progress
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
in progress
Date of the first journal publication of results
Baseline Characteristics
in progress
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
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032587
