Probiotic on Atopic Dermatitis in Infant

Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Bifidobacterium longum CCFM1029; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 74442
    • Glac Biotech Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects were between 3 months and 3 years old.
• For patients diagnosed with atopic dermatitis by a professional physician and the EASI score is greater than 5, the type and frequency of drugs used during the experiment should be recorded.
• The subject's parents agree to join the trial and sign the informed consent form.

Exclusion Criteria:

• The patient who has a history of allergic reactions, or the use of other highly sensitive or contraindicated drugs (allergy to antibiotics or antipyretics).
• The patient who has taken oral immunosuppressants and systemic steroids within the past 2 weeks.
• The patient who has consumed probiotic-related products (including drops, lozenges, capsules, powder or yogurt) within the past 1 month.
• The patient who has participated in other clinical studies within the past 1 month.
• The patient who has received immunotherapy within the past 1 year.
• The patient who suffering from major diseases (with a IC card for severe illness), congenital diseases.
• The patient who is not suitable to participate in the trial as assessed by the professional physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Subjects take one capsule containing maltodextrin daily at bedtime.
Experimental: Bifidobacterium longum CCFM1029	Dietary supplement: Bifidobacterium longum CCFM1029; Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in eczema area and severity index (EASI) scores.	Changes in eczema area and severity index (EASI) scores were assessed before and 3 months of intervention. The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.	Before and 3-month intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in eczema area and severity index (EASI) scores.	Changes in eczema area and severity index (EASI) scores were assessed after 1 month and 2 months of intervention. The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.	After 1 month and 2 months of intervention.
Changes in gut microbiota ratios.	Changes in gut microbiota ratios were assessed by NGS before and 3 months of intervention.	Before and 3 months of intervention.
Changes in infants' dermatitis quality of life (IDQOL) index.	Changes in infants' dermatitis quality of life (IDQOL) index were assessed by questionnaire before and 1-, 2- and 3-month intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.	Before and 1-, 2- and 3-month intervention.
Changes in dermatitis family impact (DFI) scores.	Changes in dermatitis family impact (DFI) scores were assessed by questionnaire before and 1-, 2- and 3-months intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.	Before and 1-, 2- and 3-month intervention.
Changes in subjects' frequency of medicine use from questionnaires.	Changes in subjects' frequency of medicine use were assessed from questionnaire before and 1-, 2- and 3-months intervention. When subjects returned to the clinic, the average daily medicine use over the past month is asked by a professional physician.	Before and 1-, 2- and 3-month intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in eczema area and severity index (EASI) scores.	Changes in eczema area and severity index (EASI) scores were assessed at 2, 4, and 6 months after discontinuation of intervention. The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.	At 2, 4, and 6 months after discontinuation of intervention.

Collaborators and Investigators

• Sponsor: Glac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; Atopic dermatitis; Allergic diseases; Intestinal flora
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: CMUH-2021001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No