臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 28, 2023
Last modified on	Aug. 31, 2024
Trial ID	jRCTs071230054

Scientific Title	Effects of microbiome from probiotics and fermented foods on the pharmacokinetics of orally administered drugs
Public Title	Effects of microbiome from probiotics and fermented foods on the pharmacokinetics of orally administered drugs

Completion date	Nov. 04, 2023
Result actual enrolment	10
Baseline Characteristics	Sex: 10 men Age : 22 (21. -43 years old) Height : 168.3 cm Weight : 58.8 kg The number is the median (Min - Max).
Participant flow	Consent was obtained voluntarily from 23 cases, and medical examinations were conducted on these 23 individuals. Prior to administration, 10 were determined to be eligible. In Study 1 (without administration of probiotics), 10 subjects completed the study, while in Study 2 (with administration of probiotics), 3 participants withdrew (refused), and 7 completed the study.
Adverse events	No serious adverse events occurred during the trial. In addition, no drug-related adverse events were observed. The following event was considered to be non-causal: Subject #4: Elevated triglyceride levels.
Outcome measures	Tacrolimus, valaciclovir, and candesartan cilexetil were administered, and the area under the concentration-time curve (AUC) for each drug was calculated based on the blood concentrations of tacrolimus, acyclovir, and candesartan obtained. No significant changes in AUC were observed following the administration of probiotics.
Brief summary	The results of this study, which evaluated whether the concomitant use of probiotics inhibits the conversion of drugs in the intestine and affects drug absorption, demonstrated that the concomitant use of the gastrointestinal regulator did not impact the pharmacokinetics of tacrolimus, valaciclovir, and candesartan cilexetil.
Date of posting of results summaries	Aug. 31, 2024
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs071230054

Contact for Scientific Queries	Name	Yoshihara Tatsuya
	Affiliation	SOUSEIKAI Fukuoka Mirai Hospital
	Address	3-5-1, Kashiiteriha, Higashi-ku, Fukuoka
	Telephone	+81-92-662-3608
	E-mail	tatsuya-yoshihara@lta-med.com
Contact for Public Queries	Name	Mine Yukitoshi
	Affiliation	SOUSEIKAI Fukuoka Mirai Hospital
	Address	3-5-1, Kashiiteriha, Higashi-ku, Fukuoka
	Telephone	+81-92-662-3608
	E-mail	yukitoshi-mine@lta-med.com

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 02, 2023
Actual date of first enrollment		Oct. 02, 2023
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	1. Japanese healthy male who is capable to understand and sign the informed consent 2. 20-45 years of age 3. BMI 17.6-26.4 4. good health as determined by physical examination, vital signs and laboratory tests.
	Exclusion Criteria	1. history of allergy to any drugs 2. medical attention within 2 months prior to participation 3. donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4. donation of 400 mL or more of blood within 12 weeks prior to participation 5. recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6. history of drug abuse 7. alcohol abuse 8. taking drugs or healthy foods which may affect drug metabolism
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		healthy male
Intervention(s)		1. Single oral dose of tacrolimus hydrate, valacyclovir hydrochloride, candesartan cilexetil 2. Single oral dose of probiotics containing Bacillus subtilis, tacrolimus hydrate, valacyclovir hydrochloride, candesartan cilexetil
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		1. blood drug concentration (tacrolimus, valacyclovir, candesartan cilexetil and their major metabolites) 2. pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.)
Secondary Outcome(s)

Primary Sponsor

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Department of Pharmacy, Kyushu University Hospital
Secondary Sponsor	Applicable

Name of Certified Review Board	Kyushu University Certified Institutional Review Board for Clinical Trials
Address	3-1-1, Maidashi Higashi-ku Fukuoka, Japan, Fukuoka, Fukuoka
Telephone	+81-92-642-5082
E-Mail	byskenkyu@jimu.kyushu-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 18, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Aug. 31, 2024	(this page)	Changes
2	Oct. 04, 2023	Detail	Changes
1	Aug. 28, 2023	Detail

List of change history