臨床研究等提出・公開システム

Scientific Title	Effect of Kale drink on defecation in patients with constipation -A single-arm open label study-
Public Title	Kale drink study in patients with constipation

Contact for Scientific Queries	Name	Ogawa Yoshihiro
	Affiliation	Kyushu University
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka city, Fukuoka
	Telephone	+81-92-642-5297
	E-mail	yogawa@intmed3.med.kyushu-u.ac.jp
Contact for Public Queries	Name	Ogino Haruei
	Affiliation	Kyushu University
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka city, Fukuoka
	Telephone	+81-92-642-5286
	E-mail	ogino@intmed3.med.kyushu-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 28, 2020
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with constipation diagnosed by Roma IV criteria
	Exclusion Criteria	Patients with allergy of Kale
	Age Minimum	50age old over
	Age Maximum	90age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic constipation
Intervention(s)		Kale drink
Health Condition(s) Keyword		Constipation
Intervention(s) Keyword		Kale
Health Condition(s) Code		K590
Primary Outcome(s)		Changes of microbiota in intestinal microbiota
Secondary Outcome(s)		(Complete) spontaneous bowel movement

Source of Monetary Support / Secondary Sponsor	FANCL Corporation
Secondary Sponsor	Applicable

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Kyushu University
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka
Telephone	+81-92-642-5082
E-Mail	byskenkyu@jimu.kyushu-u.ac.jp
Approval Status	Approval
Date of approval	June. 15, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history