UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008858 |
|---|---|
| Receipt number | 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 16:12:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
YASUHIRO@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010400
