NCT05286047

Probiotic on Atopic Dermatitis in Infant

Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Glac Biotech Co., Ltd · Industry
• Sex: All
• Age: 3 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial will be carried out in China Medical University Hospital. The overall plan is a double-blind trial. All recruited 3 months-3 years old atopic dermatitis (AD) patients are divided into two groups, 50 in each group and 100 in two groups. The two groups are placebo and Bifidobacterium longum CCFM1029. The entire evaluation plan lasts for 3 months. The number of probiotic bacteria is 5 billion per capsule, and the number of bacteria taken by the subjects is 5 billion per day (one capsule before bed each day). During the planning period, the eczema area and severity index (EASI) score of the patient's dermatitis was evaluated every month, and the score differences of dermatitis before and after taking probiotics was observed. In addition, subjects must perform two fecal samplings before and after the trial, and the isolated DNA was analyzed using the next-generation high-throughput sequencing method (NGS) for subject fecal flora changes. Comparing the two groups before and after taking the capsule, whether the intestinal flora changed. Statistical analysis of the relationship between changes in intestinal flora and the degree of AD. Through the above test, the investigators evaluated whether Bifidobacterium longum CCFM1029 can regulate the pediatric intestinal flora and relieve the inflammatory response in the body, thereby regulating atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium longum CCFM1029	Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime.
DIETARY_SUPPLEMENT	Placebo	Subjects take one capsule containing maltodextrin daily at bedtime.

Timeline

• Start date: 2022-09-23
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2022-03-18
• Last updated: 2026-01-12

Locations

1 site across 1 country: Taiwan