UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043072 |
|---|---|
| Receipt number | R000049075 |
| Scientific Title | Observational study on the changes in oral and intestinal microbiota before and after the use ofantimicrobials |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2024/10/02 13:57:57 |
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Basic information
Public title
Observational study on the changes in oral and intestinal microbiota before and after the use ofantimicrobials
Acronym
Observational study on the changes in oral and intestinal microbiota before and after the use ofantimicrobials
Scientific Title
Observational study on the changes in oral and intestinal microbiota before and after the use ofantimicrobials
Scientific Title:Acronym
Observational study on the changes in oral and intestinal microbiota before and after the use ofantimicrobials
Region
| Japan |
Condition
Condition
Infectiouse diseases
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the impact of carbapenems on microbiomes by comparing patients who used carbapenems with those who used cephamycin/oxacephem antibiotics and who did not used any antibiotics
Basic objectives2
Others
Basic objectives -Others
To examine if the microbiome can be an indicator of the adequate use of antibiotics and how it can be utilized as an indicator
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The composition ratio of each type of microbes and that of functional genes of microbiomes
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
1) Patients who are 20 years or over and a Japanese national
2) Patients who are prescribed carbapenems and cephamycin/oxacephem antibiotics in the department of infectious diseases, general internal medicine, emergency medicine, or critical care of the NCGM
3) Patients who will continuously take antibiotics for more than 3 days, including the first day of taking the antibiotics
Key exclusion criteria
1) Patients who have used antibiotics during the past 2 months
2) Patients who need to take carbapenems and cephamycin/oxacephem antibiotics together with other antibiotics
3) Patients to whom rectal swab sample collection cannot be applied e.g., patients with a stoma
4) Patients who have had a colectomy
5) Patients with a history of any hypersensitivity to carbapenems and cephamycin/oxacephem antibiotics
6) Patients whom the investigator deemed to be inappropriate for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Saito |
Organization
National Center for Global Health and Medicine (NCGM)
Division name
Disease Control and Prevention Center (DCC)
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
03-3202-7181
ssaito@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Saito |
Organization
National Center for Global Health and Medicine (NCGM)
Division name
Disease Control and Prevention Center (DCC)
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
03-3202-7181
Homepage URL
ssaito@hosp.ncgm.go.jp
Sponsor or person
Institute
Disease Control and Prevention Center (DCC), National Center for Global Health and Medicine (NCGM)
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI) from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine (NCGM)
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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 | 01 | Month | 22 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1341321X24001624?via%3Dihub
Number of participants that the trial has enrolled
23
Results
MP treatment may cause larger impact on the feces microbiome than CMZ in Japanese patients.
Results date posted
| 2024 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Five feces (CMZF and MPF) and five saliva samples (CMZS and MPS) each were included in the CMZ and the MP groups. Ten feces samples (CF) and ten saliva samples (CS) were included in the control group. In the CMZ and MP groups, feces and saliva samples were collected from the same patients in four and three cases, respectively. In the control group, feces and saliva samples were collected from the same persons in all ten cases. The frequency of exposure to antimicrobial agents within six months differed among the three groups, both in the feces and saliva. The MP group showed the highest frequency of exposure to antimicrobial agents. Variations were noted among the feces samples of the three groups regarding the use of probiotics within the previous month and history of peptic ulcer disease, with both being most common in the MP group.
Participant flow
This was a multicenter prospective observational study that enrolled participants between October 2020 and October 2022. The following subjects were included in the antimicrobial treatment group 1 Japanese patients aged 20 years or older, 2 those started on CMZ or MP for suspected infection, and 3 those expected to be treated with the agent for at least three consecutive days. As for the control group, we recruited Japanese volunteers aged 20 years or older who were healthcare professionals with no history of antimicrobial use within the previous month.
Feces and saliva were collected at the early (days 1 to 3) and late (days 4 to 30) periods of antimicrobial administration for the antimicrobial treatment group and once for the control group. Patients from whom samples could not be obtained from the rectum or feces (e.g.colostomy patients), those with a history of colon resection, or those with history of hypersensitivity to the study antimicrobials were excluded.
Adverse events
N/A
Outcome measures
Alpha diversity was calculated as Shannon entropy using the CLC Genomic Workbench. Beta diversity was measured as the weighted and unweighted UniFrac distance based on the OTU table using CLC Genomic Workbench. Permutational multivariate analysis of variance (PERMANOVA) was performed to compare beta diversity using the CLC Genomic Workbench, and the Bonferroni correction was applied. The relative abundance of taxa was calculated from an unrarefied OTU table. For differential abundance analysis at the genus level, groups were compared using false discovery rate (FDR) correction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is a single-center, prospective, observational study with minimally invasive. Stool and saliva samples are collected from patients two times: before taking meropenem belonging to the carbapenem class, cefmetazole belonging to the cephamycin class, or flomoxef sodium belonging to the oxacephem class (Day1) or Day2, and Day 4-8. The study investigates the change over time of microbiomes when the patient took carbapenem and cephamycin/oxacephem antibiotics, respectively, and compares patients who used the antibiotics and did not use any.
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049075
