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Clinical study to investigate the therapeutic effect of 1-kestose on atopic dermatitis

Clinical study to investigate the therapeutic effect of 1-kestose on atopic dermatitis - Effect of 1-kestose on atopic dermatitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008858
Enrollment
120
Registered
2012-09-05
Start date
2012-09-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Interventions

Intervention (1-kestose) group Period: 12 weeks Dose: 1g/day (age &lt
1 year), 2g/day (1-3 years), or 3g/day (4-6 years). A half dose per time, twice per day. Control (maltose) group Period and dose: same as the intervention group.

Sponsors

Tokai University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Severity score based on the Severity Scoring of Atopic Dermatitis (SCORAD) 6 weeks after the begining of the administration

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactYasuhiro Koga

Tokai University School of Medicine Laboratory for infectious disease

YASUHIRO@is.icc.u-tokai.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026