Clinical trial for the evaluation of the efficacy and safety of live or killed Lactobacillus sakei Probio65 on atopic dermatitis in children

A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of live or killed Lactobacillus sakei Probio65 on atopic dermatitis in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003928

Enrollment

Registered

2019-05-16

Start date

2014-06-05

Completion date

Unknown

Last updated

2019-05-20

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

Conditions

None listed

Interventions

Dietary Supplement, Others(Lactobacillus sakei Probio65 cell (live and dead)) : ? Names of the Intervention group

Test group I (live cells), Test group II (dead cells), Control group (Placebo) ? Effective Materials in Test groups: Live or dead cells of a Lactobacillus strain (Lactobacillus sakei Probio65) ? The m

Total 12 weeks (84 days)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who agreed to participate in this test and presented a document, voluntarily signed by the subject, the parent, or legal representative 2) Those who aged 3 to 18 years 3) Those who have intermittent or persistent atopic dermatitis symptoms for more than 6 months 4) Those who have SCORAD scores between 20 and 50 (mild-moderate)

Exclusion criteria

Exclusion criteria: 1) Those who have severe skin disease or systemic disease in addition to atopic dermatitis 2) Those who administered antibiotics, corticosteroids, antihistamines, or immuno-suppressants within 4 weeks of screening 3) Those who administered medicines, herbal medicine, or health functional foods to improve the symptom of atopic dermatitis within 4 weeks of screening 4) Those who received phototherapy within 4 weeks of screening 5) Those who have taken probiotics within 2 weeks of screening 6) Those who plan to participate in other tests during this clinical trial 7) Those who participated in other clinical trials within 4 weeks of the start of this clinical trial 8) Those who considered as inappropriate for this clinical trial by the judgment of the tester

Design outcomes

Primary

Measure	Time frame
SCORAD(SCORing of Atopic Dermatitis) total score;Adverse reaction; Signs of vitality (blood pressure, pulse), body measurement (body weight); Clinical pathology test (hematological test, blood chemistry test, urine test)	—

Secondary

Measure	Time frame
SCORAD objective score (Range and degree of lesion);SCORAD subjective score (Pruritus, sleep disorder);Investigator’s Global Assessment (IGA);Changes in skin condition (moisture, oil, pH);Immune factors in the blood (Eosinophil (count), IgE, ECP, CCL17 (TARC), and CCL27 (CTACK))	—

Countries

Korea, Republic of

Contacts

Public ContactSeul-Ki Lim

Oracle Dermatologic Clinic

ddolki21@gmail.com+82-44-868-0075

Outcome results