Probiotic on Atopic Dermatitis in Infant

NCT05286047 | Completed

• 1 other identifier: CMUH-2021001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atopic dermatitis; Probiotics; Intestinal flora; Allergic diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in eczema area and severity index (EASI) scores.

  After 1 month and 2 months of intervention.

• Changes in gut microbiota ratios.

  Before and 3 months of intervention.

• Changes in infants' dermatitis quality of life (IDQOL) index.

  Before and 1-, 2- and 3-month intervention.

• Changes in dermatitis family impact (DFI) scores.

  Before and 1-, 2- and 3-month intervention.

• Changes in subjects' frequency of medicine use from questionnaires.

  Before and 1-, 2- and 3-month intervention.

Study Arms (2)

Bifidobacterium longum CCFM1029

EXPERIMENTAL

Dietary Supplement: Bifidobacterium longum CCFM1029

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Bifidobacterium longum CCFM1029 DIETARY_SUPPLEMENT

Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime.

Bifidobacterium longum CCFM1029

Placebo DIETARY_SUPPLEMENT

Subjects take one capsule containing maltodextrin daily at bedtime.

Placebo

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glac Biotech Co., Ltd: lead

Study Sites (1)

Glac Biotech Co., Ltd.

Tainan, 74442, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R&D Director

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: September 23, 2022
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

TW (1)