臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 25, 2024
Last modified on	Nov. 25, 2024
Trial ID	jRCTs041240133

Scientific Title	Effects of oligosaccharide (kestose) and dietary fiber (inulin) administration on intestinal microbiota of atopic dermatitis
Public Title	Prebiotic Intervention Trial in Atopic Dermatitis

Contact for Scientific Queries	Name	Sugiura Kazumitsu
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo Kutsukake-tyo Toyoake-shi Aichi
	Telephone	+81-562-93-9256
	E-mail	k-sugiura@fujita-hu.ac.jp
Contact for Public Queries	Name	Aiko Takanaru
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo Kutsukake-tyo Toyoake-shi Aichi
	Telephone	+81-562-93-9256
	E-mail	takanaru.aiko@fujita-hu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 25, 2024
Actual date of first enrollment
Target sample size		30
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. patients who, after receiving full explanation and with full understanding, give written consent of their own free will to participate in this study 2. patients who are at least 3 years old at the time of consent
	Exclusion Criteria	Patients deemed inappropriate by the principal investigator or subinvestigator, patients who received antibiotics during the week prior to stool sampling, and patients undergoing stress testing for food allergies.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		atopic dermatitis
Intervention(s)		Prebiotic group: 3 g of kestose and inulin twice daily, morning and evening. Non-prebiotic group: Observation only.
Health Condition(s) Keyword		atopic dermatitis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Comparison of intestinal microbiota and intestinal metabolites in patients with atopic dermatitis before and after treatment
Secondary Outcome(s)		Skin symptom changes (POEM, ADCT, DLQI, EASI, IGA, BSA, VAS, NRS) Blood tests (IL-10, TRAC, general biochemistry) Evaluation of adverse events (exacerbation of atopic dermatitis, gastrointestinal disorders, and other causally undeniable adverse events)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
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	Oct. 21, 2024

Plan to share IPD	Yes
Plan description	At the beginning of the study, the names of research subjects will be replaced with identification codes (a combination of letters and numbers) and a corresponding list will be prepared. The following materials to be obtained in this research shall be stored under the responsibility of the principal investigator, with data password-protected and paper materials stored securely in a locked cabinet. The storage period is five years from the date of completion of the specific clinical research. When destroyed, they should be shredded or incinerated in a manner that makes them unrecoverable. (1) Research protocols, implementation plans, documents pertaining to the explanation to the subjects of the specified clinical research and their consent, summary reports, and other documents prepared by the principal investigator pursuant to the provisions of this Ministerial Ordinance, or copies thereof. (2) Documents received from an accredited clinical research review committee pertaining to review and opinion services (3) Documents related to monitoring (4) Original documents, etc. (5) Contracts pertaining to the implementation of the specified clinical research (6) Documents describing the outline of the drug, etc. to be used in the specified clinical research, and records of the date of manufacture, serial number or production code of the drug, etc. and other records related to the manufacture of the drug, etc., the quantity and date of acquisition, and records of disposal of the drug, etc.

Plan to share IPD

Yes

Plan description

At the beginning of the study, the names of research subjects will be replaced with identification codes (a combination of letters and numbers) and a corresponding list will be prepared. The following materials to be obtained in this research shall be stored under the responsibility of the principal investigator, with data password-protected and paper materials stored securely in a locked cabinet. The storage period is five years from the date of completion of the specific clinical research. When destroyed, they should be shredded or incinerated in a manner that makes them unrecoverable. (1) Research protocols, implementation plans, documents pertaining to the explanation to the subjects of the specified clinical research and their consent, summary reports, and other documents prepared by the principal investigator pursuant to the provisions of this Ministerial Ordinance, or copies thereof. (2) Documents received from an accredited clinical research review committee pertaining to review and opinion services (3) Documents related to monitoring (4) Original documents, etc. (5) Contracts pertaining to the implementation of the specified clinical research (6) Documents describing the outline of the drug, etc. to be used in the specified clinical research, and records of the date of manufacture, serial number or production code of the drug, etc. and other records related to the manufacture of the drug, etc., the quantity and date of acquisition, and records of disposal of the drug, etc.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none