UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045813 |
|---|---|
| Receipt number | R000052300 |
| Scientific Title | Effect of acid exposure in the duodenum on colon perception in healthy individuals |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2021/10/20 19:34:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tomita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052300
