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Probiotic on Atopic Dermatitis in Infant

NCT05286047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Glac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2025-05-28
Completion
2025-05-28

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286047 on ClinicalTrials.gov