A randomized, open-label, parallel group study to evaluate the efficacy and safety of the oral administration of Bifidobacterium animalis subsp. lactis LKM512 in patients with atopic dermatitis

A randomized, open-label, parallel group study to evaluate the efficacy and safety of the oral administration of Bifidobacterium animalis subsp. lactis LKM512 in patients with atopic dermatitis - Efficacy and safety of Bifidobacteria LKM512 in patient with atopic dermatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005695

Enrollment

Registered

2011-06-01

Start date

2011-06-01

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

The volunteer were given an 8-week treatment with oral administration of Bifidobacteria LKM512 tablet (10 billion bacterial cells/tablet) two times per day. The volunteer were given an 8-week treatmen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who were diagnosed as having moderate or severe atopic dermatitis according to the criteria of Hanifin and Rajka. (2) Male or female subjects (under 75 years old)

Exclusion criteria

Exclusion criteria: (1) Patients who are taking oral Bifidobacteria LKM512 daily (2) Patients who were diagnosed as having milk allergy (3) Patients who was enrolled in other trails within a month. (4) Inappropriate cases evaluated by doctors

Design outcomes

Primary

Measure	Time frame
Score of itch after 4 weeks and 8 weeks of administration	—

Secondary

Measure	Time frame
Improvement of dermatological symptoms QOL Intestinal microbiota	—

Countries

Japan

Outcome results

None listed

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