UMIN-CTR Clinical Trial

Basic information
Public title	Effect of acid exposure in the duodenum on colon perception in healthy individuals
Acronym	Effect of acid exposure in the duodenum on colon perception in healthy individuals
Scientific Title	Effect of acid exposure in the duodenum on colon perception in healthy individuals
Scientific Title:Acronym	Effect of acid exposure in the duodenum on colon perception in healthy individuals
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of stress load on the large intestine due to acid injection into the duodenum in healthy subjects.
Basic objectives2	Others
Basic objectives -Others	To clarify the effect of acid stimulation on the duodenum on the perception of the large intestine.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rectum initial perception threshold rectum pain threshold
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	Treatment
Type of intervention	Other
Interventions/Control_1	HCl 100ml single time 10minutes
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	20 to 80 years old Those who do not have significant subjective symptoms. Taking gastrointestinal motility improver, gastric acid secretion inhibitor (H2 receptor antagonist, proton pump inhibitor), gastric mucosa protectant, prostaglandin preparation, antidepressant, anxiolytic, sleep inducer, antipsychotic Those who have not. A person who understands the contents of this research and obtains written consent to participate in the research.
Key exclusion criteria	Those who are clearly having diseases that cause upper abdominal gastrointestinal symptoms such as malignant tumors, peptic ulcers, heart diseases, systemic diseases (neurological diseases such as Parkinson's disease and metabolic diseases such as diabetes). Persons with clear causes of upper abdominal gastrointestinal symptoms such as overdrinking, overeating, taking NSAIDs, and extremely strong stress. Persons with a history of upper gastrointestinal surgery such as stomach and esophagus. Persons with severe liver dysfunction and renal dysfunction. Pregnant women, lactating women, or those who wish to become pregnant during the period of participation in this study.
Target sample size	12

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	Nishinomiya
TEL	0798456661
Email	tomita@hyo-med.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Tomita
Organization	Dr.
Division name	Division of Gastroenterology,Department of Internal Medicine
Zip code	663-8501
Address	Nishinomiya
TEL	0798456661
Homepage URL
Email	tomita@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College 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	Hyogo College of Medicine
Address	1-1,Mukogawa-cho,Nishinomiya
Tel	0798456661
Email	tomita@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	2021 Year 10 Month 21 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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 24 Day
Date of IRB	2021 Year 05 Month 24 Day
Anticipated trial start date	2021 Year 10 Month 21 Day
Last follow-up date	2024 Year 12 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	2021 Year 10 Month 20 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052300