UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051289 |
|---|---|
| Receipt number | R000058409 |
| Scientific Title | Effect of endoscopic pretreatment drugs on the microbiota profile in gastric fluid microbiota analysis |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2025/06/07 11:45:53 |
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Basic information
Public title
Effect of endoscopic pretreatment drugs on the microbiota profile in gastric fluid microbiota analysis
Acronym
Effect of pretreatment drugs on gastric fluid microflora
Scientific Title
Effect of endoscopic pretreatment drugs on the microbiota profile in gastric fluid microbiota analysis
Scientific Title:Acronym
Effect of pretreatment drugs on gastric fluid microbiota analysis
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of endoscopic pretreatment drugs on gastric microbiota analysis results in 16S rDNA sequencing
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbial profiles based on 16S rDNA amplicon sequencing
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
Subjects who participated in the study entitled "Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases UMIN000040192" from April 1, 2017 to March 31, 2019, and underwent salivary microbiota analysis.
Key exclusion criteria
1) Those who performed endoscopy with either intravenous anesthesia plus pharyngeal Xylocaine spray plus one of the pre-treatment methods (mainly Xylocaine Viscose, Pronase, Gascon drop) in which the drug is swallowed beforehand, and then collected gastric juice at the time of the endoscopy
2) Those who refused to participate by opting out.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Futakuchi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-shimbashi, Minato-ku Tokyo, Japan
TEL
0334331111
futakuchi.t@gmail.com
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Futakuchi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-shimbashi, Minato-ku Tokyo, Japan
TEL
0334331111
Homepage URL
futakuchi.t@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School 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
The Jikei University School of Medicine
Address
3-25-8, Nishi-shimbashi, Minato-ku Tokyo, Japan
Tel
0334331111
futakuchi.t@gmail.com
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
| 2023 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jgh3.70141
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jgh3.70141
Number of participants that the trial has enrolled
6
Results
The total amount of extracted gDNA did not significantly differ between the six groups. The alfa-diversity indices did not significantly differ between treatment groups. Although GAS, PRO, and MIX differed significantly from the technical replicates in the weighted UniFrac distance (p = 0.03 all), no significant difference was observed in the unweighted UniFrac distance. However, significant differences were observed in the relative abundance of several bacterial microbiota at the phylum and genus levels.
Results date posted
| 2025 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Six patients, who visited the Isshi Gastrointestinal Clinic between September and October 2019, were recruited for this study.
Participant flow
All patients provided written informed consent to participate before being recruited. Gastric juice samples were aspirated with endoscopy from patients after fasting for at least 12 h and collected using Specimen Collection Containers (Cardinal Health K.K., Japan). If the collected gastric juice was less than 20 mL, sterile distilled water was added to make up a total volume of 20 mL.
Adverse events
N/A
Outcome measures
(1) amount of genomic DNA (gDNA), (2) alfa- diversity indices using the Shannon index, number of OTUs, and Chao1 index, (3) weighted and unweighted UniFrac distances, and (4) the relative abundance of phyla and genera.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was conducted in the "Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases (UMIN000040192)" in which exhaustive collection specimens were stored in 16s rRNA sequencing data.
Retrospective analysis was performed after IRB and UMIN registration.
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058409
