UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034376 |
|---|---|
| Receipt number | R000039193 |
| Scientific Title | A role of P.gingivalis and Acetaldehyde in barrier dysfunction of gastric mucosa after H.pylori eradication |
| Date of disclosure of the study information | 2019/09/15 |
| Last modified on | 2024/02/15 12:32:10 |
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Basic information
Public title
A role of P.gingivalis and Acetaldehyde in barrier dysfunction of gastric mucosa after H.pylori eradication
Acronym
Mucosal barrier dysfunction by P.gingivals and Acetaldehyde on gastric mucosa after H.pylori eradication
Scientific Title
A role of P.gingivalis and Acetaldehyde in barrier dysfunction of gastric mucosa after H.pylori eradication
Scientific Title:Acronym
Mucosal barrier dysfunction by P.gingivals and Acetaldehyde on gastric mucosa after H.pylori eradication
Region
| Japan |
Condition
Condition
Gastric cancer after H.pylori eradication
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify a phisiological role of P.gingivalis and acetaldehyde on barrier dysfunction of gastric mucosa duirng gastric carcinogenesis after H.pylori eradication
Basic objectives2
Others
Basic objectives -Others
To clarify a molecular biological mechanism of P.gingivalis and acetaldehyde on barrier dysfunction of gastric mucosa duirng gastric carcinogenesis after H.pylori eradication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mucosal damage of atrophic mucosa by the stimulation of P.gingivalis LPS or LPS and acetaldehyde
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
P.gingivalis LPS low concentration
Interventions/Control_2
P.gingivalis LPS high concentration
Interventions/Control_3
P.gingivalis LPS + Acetaldehyde low
Interventions/Control_4
P.gingivalis LPS + Acetaldehyde high
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
post-eradication GC lesions, which were newly discovered later than 24 months after successful eradication.
Key exclusion criteria
1) patients younger than 20 years old or older than 85 years old; 2) patients with a history of chemotherapy, radiotherapy or upper abdominal surgery; 3) patients taking nonsteroidal anti-inflammatory drugs, antibiotics, or any acid secretion inhibitors; 4) patients with serious medical conditions; 5) patients suffering from mental disorders; 6) patients who might be pregnant; 7) patients with inappropriate specimens; 8) patients with contraindication for endoscopic biopsy or gastrin injection; and 9) patients who refused to participate in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kaname |
| Middle name | |
| Last name | Uno |
Organization
Tohoku University Hospital
Division name
Gastroenterology
Zip code
981-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai, Miyagi, Japan
TEL
022-717-7171
kaname-1@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kaname |
| Middle name | |
| Last name | Uno |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
981-8574
Address
1-1 Seiryo-cho, aobaku, Sendai, Miyagi, Japan
TEL
022-717-7171
Homepage URL
kaname-1@umin.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Tohoku University Hospital IRB
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi
Tel
022-728-4105
office@nrs.hosp.tohoku.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
| 2019 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37943385/
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
36
Results
There is no difference in decrease of mucosal impedance of the background mucosa of gastric cancer between the stimulation with Pg.LPS and that with Pg.LPS + acetaldehyde.
Results date posted
| 2024 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
36 patients with GC detected at least 2 years after successful H. pylori eradication therapy (post-eradication GC)
Participant flow
Under endoscopic inspection, three biopsy samples were obtained from background mucosa suffering from GC, and they were separately applied to histological studies, a mini-Ussing chamber system (mUCs), and molecular biological studies.
Adverse events
none
Outcome measures
biopsy samples to mUCs to evaluate changes in the mucosal barrier function by external stimulations
The degree of inflammation, activity, atrophy, and metaplasia of endoscopic biopsy specimens was evaluated based on the uSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039193
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