臨床研究等提出・公開システム

Date of registration	Aug. 18, 2026
Last modified on	Aug. 18, 2026
Trial ID	jRCT1030260407

Scientific Title	An Exploratory Clinical Study of Small Intestinal Microbiota-Host Interactions in Patients with Crohn's Disease
Public Title	An Exploratory Clinical Study of Small Intestinal Microbiota-Host Interactions in Patients with Crohn's Disease

Contact for Scientific Queries	Name	Nomura Kei
	Affiliation	Juntendo University
	Address	2-1-1 Hongo Bunkyo-ku Tokyo
	Telephone	+81-3-3813-3111
	E-mail	ke-nomura@juntendo.ac.jp
Contact for Public Queries	Name	Nomura Kei
	Affiliation	Juntendo University
	Address	2-1-1 Hongo Bunkyo-ku Tokyo
	Telephone	+81-3-3813-3111
	E-mail	ke-nomura@juntendo.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Aug. 18, 2026
Target sample size		40
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients aged between 18 years or older at the time of obtaining consent. 2. Patients diagnosed with Crohn's disease who are scheduled to undergo small-bowel endoscopy as part of routine clinical care 3. Those who have received sufficient explanation for participation in this research and have obtained written consent of the subject's own free will after sufficient understanding.
	Exclusion Criteria	1. Patients with a history of total gastrectomy. 2. Patients who have taken antibiotics within 4 weeks prior to the examination date. 3. Pregnant patients 4. Other Patients who are judged to be unsuitable as research subjects by the principal investigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Crohn's disease
Health Condition(s) Keyword		Crohn's disease
Health Condition(s) Code		A03
Primary Outcome(s)		Association of small intestinal microbiota composition with disease characteristics, inflammatory findings, and clinical course in patients with Crohn's disease.
Secondary Outcome(s)		Exploratory analyses of the small intestinal microbiota, including comparisons among specimen types and sampling sites, associations with host factors, longitudinal changes, comparisons with previously obtained data, and comparisons between patients with Crohn's disease and non-Crohn's disease control subjects.

Primary Sponsor	Juntendo University Hospital

Source of Monetary Support	Meiji Holdings Co., Ltd.
Secondary Sponsor	Applicable

Name of Certified Review Board	Medical Department Ethics Committee, Juntendo University
Address	2-1-1 Hongo,Bunkyo-ku, Tokyo, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	Aug. 06, 2026

Plan to share IPD	No

Secondary ID(s)	該当なし

Countries of Recruitment（Except Japan）	none