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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008858
Receipt No. R000010400
Scientific Title Clinical study to investigate the therapeutic effect of 1-kestose on atopic dermatitis
Date of disclosure of the study information 2012/09/05
Last modified on 2017/03/13

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Basic information
Public title Clinical study to investigate the
therapeutic effect of 1-kestose on atopic
dermatitis
Acronym Effect of 1-kestose on atopic dermatitis
Scientific Title Clinical study to investigate the
therapeutic effect of 1-kestose on atopic
dermatitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiro Koga
Organization Tokai University School of Medicine
Division name Laboratory for infectious disease
Zip code
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
1st name
Middle name
Last name Yasuhiro Koga
Organization Tokai University School of Medicine
Division name Laboratory for infectious disease
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 06 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010400

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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