UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042361 |
|---|---|
| Receipt number | R000048346 |
| Scientific Title | Prospective exploratory study of the relationship between the development of gastrointestinal diseases and bile acids and gut microbiota. |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2024/12/15 15:25:25 |
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Basic information
Public title
Study of the relationship between the development of gastrointestinal diseases and bile acids and gut microbiota.
Acronym
Study of the relationship between the development of gastrointestinal diseases and bile acids and gut microbiota.
Scientific Title
Prospective exploratory study of the relationship between the development of gastrointestinal diseases and bile acids and gut microbiota.
Scientific Title:Acronym
Prospective exploratory study of the relationship between the development of gastrointestinal diseases and bile acids and gut microbiota.
Region
| Japan |
Condition
Condition
gastrointestinal diseases, especially duodenal tumors.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether changes in the composition of bile acids exposed to the gastrointestinal tract and gut microbiota are involved in the development of gastrointestinal diseases, especially duodenal tumors.
Basic objectives2
Others
Basic objectives -Others
To clarify the mechanisms and risk factors for the development of gastrointestinal diseases, especially duodenal tumors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bile acid composition and gut microbiota profile in patients with gastrointestinal diseases
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who over 20years and perform upper or lower gastrointestinal endoscopy or biliary endoscopy
Key exclusion criteria
(1)Patient with disorder about the function of blood coaglation
(2)Patients with impossibility for the adaptation according to the guideline for antithrombotic drugs of Japanese gastroenterological endoscopy society
(3)Patient with important organ dysfunction
(4)Patient with another inappropreate reasons decided by the doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University, school of medicine
Division name
Gastroenterology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3437
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Kubosawa |
Organization
Keio University, school of medicine
Division name
Gastroenterology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3437
Homepage URL
yoooko102@keio.jp
Sponsor or person
Institute
Keio 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
Keio University, school of medicine
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-3353-1211
keio-ctr-coijim@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC11319767/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC11319767/
Number of participants that the trial has enrolled
60
Results
No significant differences in microbiota were observed between duodenal tumor patients and healthy controls. In patients with duodenal tumor, the lithocholic acid concentration in duodenal was significantly lower than in healthy controls.
Results date posted
| 2024 | Year | 12 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged over 20 years who underwent endoscopic treatment for duodenal tumor or esophagogastroduodenoscopy and willingly consented to participate in this study were included.
Patients with liver disease, liver failure, antibiotic use within one month, abnormal blood coagulation, inability to manage anticoagulation or platelet medication following the guidelines for gastrointestinal endoscopy, severe organ damage, or other cases deemed inappropriate for enrollment by the physician in charge were excluded.
Participant flow
Patients stopped eating the night before, and the procedure was performed with at least 12 h of abstinence from food. During the procedure, benzodiazepine was used for sedation, and scopolamine butylbromide or glucagon was used as antispasmodic. Bile secretagogue was not administered. The endoscope was inserted into the descending part of the duodenum without suction. After spraying 100 mL of saline solution, the duodenal fluid was aspirated through the endoscope tube and collected, quickly frozen with liquid nitrogen, and stored at - 80 degrees celsius. After duodenal fluid collection, two pieces of normal mucosa were collected from the descending part of the duodenum using sterile biopsy forceps for microbiome analysis. Furthermore, specimens were soaked overnight in RNAlater (Thermo Fisher Scientific, Waltham, MA, USA) and stored at -80 degrees celsius. In patients with duodenal tumors, the tissue was collected from the normal mucosa at a distance that would not affect tumor resection.
Adverse events
In this study, duodenal mucosa is collected using biopsy forceps for analysis of the microbiota in addition to the usual medical examination. A nationwide tally by the Japanese Society of Gastrointestinal Endoscopy (during 5 years from 2008 to 2012) reported that the frequency of bleeding after esophagogastroduodenoscopy including biopsy was 300/11,265,684 (0.0026%) and that after colonoscopy was 75/3,815,118 (0.0020%).
No adverse events actually occurred in the study.
Outcome measures
The composition of bile acids in duodenal fluid and serum bile acid, profile of intestinal microbiota, age, sex, medication, H. pylori eradication history, lesion characteristics, and histopathological findings.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of the analysis have been published in an article.
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048346
