UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to investigate the therapeutic effect of 1-kestose on atopic dermatitis
Title of the study (Brief title)	Effect of 1-kestose on atopic dermatitis
Region	Japan

Condition
Condition	Atopic dermatitis
Classification by specialty	Clinical immunology Pediatrics Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the clinical effect of 1- kestose, a fructo-oligosaccharide, on atopic dermatitis, based on a multicenter randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Severity score based on the Severity Scoring of Atopic Dermatitis (SCORAD) 6 weeks after the begining of the administration
Key secondary outcomes	1. SCORAD scores 12 weeks after the begining of the administration and 6 weeks after the end of the administration 2. Bifidobacterial count and strain structure, staphylococcus aureus count 3. Permeability test of the intestinal mucosa (lactulose/mannitol load test) 4. Bloot tests (white blood cell count, eosinophil count, immunoglobulin E, ImmunoCAP-ovalbumin/milk/mites, Thymus and Activation-Regulated Chemokine)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intervention (1-kestose) group Period: 12 weeks Dose: 1g/day (age < 1 year), 2g/day (1-3 years), or 3g/day (4-6 years). A half dose per time, twice per day.
Interventions/Control_2	Control (maltose) group Period and dose: same as the intervention group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with atopic dermatitis 2. "Severe" or milder disease according to the "Guidelines for the Treatment of Atopic Dermatitis 2005" by the Japan Health Labour Sciences Research Group 3. Non-user of external corticosteroids or users of external corticosteroids that are classified as "strong" or weaker.
Key exclusion criteria	1. Users of external corticosteroids that are classified as "very strong" or "stronger" 2. Patients who regularly use probiotics/prebiotics other than 1-kestose for therapeutic purposes 3. Patients who regularly use antibiotics 4. Patients who are judged as ineligible by doctor in charge
Target sample size	120

Research contact person
Name of lead principal investigator	Yasuhiro Koga
Organization	Tokai University School of Medicine
Division name	Laboratory for infectious disease
Address	Isehara, Kanagawa prefecture, 259-1193 Japan
TEL	0463-93-1121
Email	YASUHIRO@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Yasuhiro Koga
Organization	Tokai University School of Medicine
Division name	Laboratory for infectious disease
Address	Isehara, Kanagawa prefecture, 259-1193 Japan
TEL	0463-93-1121
Homepage URL
Email	YASUHIRO@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	B Food Science, Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立病院機構福岡病院小児科 国立病院機構福岡東医療センター小児科 福岡大学病院小児科

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 04 Day
Anticipated trial start date	2012 Year 09 Month 10 Day
Last follow-up date	2014 Year 04 Month 30 Day
Date of closure to data entry	2015 Year 08 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 05 Day
Last modified on	2017 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010400