UMIN-CTR Clinical Trial

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

Infectiouse diseases

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The composition ratio of each type of microbes and that of functional genes of microbiomes

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Syo
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

Email

ssaito@hosp.ncgm.go.jp

Name of contact person

1st name	Syo
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

Email

ssaito@hosp.ncgm.go.jp

Institute

Disease Control and Prevention Center (DCC), National Center for Global Health and Medicine (NCGM)

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Global Health and Medicine (NCGM)

Address

1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

Tel

03-3202-7181

Email

kenkyu-shinsa@hosp.ncgm.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

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 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.

Registered date

2021

Year

01

Month

21

Day

Last modified on

2021

Year

01

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049075