臨床研究等提出・公開システム

Date of registration	Jan. 18, 2022
Last modified on	Mar. 18, 2026
Trial ID	jRCTs041210128

Scientific Title	The effects of synbiotic 1-kestose and Bifidobacterium longum on the gut microbiota in patients with cancer therapy
Public Title	The effects of synbiotics on the gut microbiota in patients with cancer therapy

Contact for Scientific Queries	Name	Hirooka Yoshiki
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
	Telephone	470-1192
	E-mail	yoshiki.hirooka@fujita-hu.ac.jp
Contact for Public Queries	Name	Funasaka Kohei
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
	Telephone	+81-562-93-2688
	E-mail	k-funa@fujita-hu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 18, 2022
Target sample size		200
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding. 2. Patients aged 20 at the time of consent. 3. Patients who have been receiving chemotherapy.
	Exclusion Criteria	Patients who are judged to be inappropriate by the investigator and the investigator.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		cancer patients
Intervention(s)		Assign patients to either kestose plus B. longum (synbiotics) administration group or non-administration group.
Primary Outcome(s)		Evaluation of the intestinal microbiota and the Bristol stool scale
Secondary Outcome(s)		: Determining overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) according to Response Evaluation Criteria (RECIST 1.1). : Improvement of nutrition state (body weight, muscle mass, body cell mass, phase angle, serum albumin) : Evaluating nutrition state using Visual Analogue Scale (VAS) : Assessing performance status : Evaluating adverse events using CTCAE v5.0 : Characterizing overall survival (OS) : Assessing Liver function Child-Pugh (CP) score and the Albumin-Bilirubin (ALBI) Grade

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Fujita Health University Certified Review Board
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi, Aichi
Telephone	+81-562-93-2865
E-Mail	crb-f@fujita-hu.ac.jp
Approval Status	Approval
Date of approval	Jan. 07, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Mar. 18, 2026	(this page)	Changes
5	Dec. 12, 2025	Detail	Changes
4	Feb. 18, 2025	Detail	Changes
3	June. 14, 2023	Detail	Changes
2	Dec. 28, 2022	Detail	Changes
1	Jan. 18, 2022	Detail

List of change history