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Completed

NCT Number: NCT05286047

Probiotic 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.

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Key information

Conditions

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

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glac Biotech Co., Ltd.

Tainan, 74442, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifidobacterium longum CCFM1029

Dietary Supplement

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

Placebo

Dietary Supplement

Subjects take one capsule containing maltodextrin daily at bedtime.

Primary outcomes

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

    Time frame: Before and 3-month intervention.

    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.

Secondary outcomes

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

    Time frame: After 1 month and 2 months of intervention.

    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.

  2. Changes in gut microbiota ratios.

    Time frame: Before and 3 months of intervention.

    Changes in gut microbiota ratios were assessed by NGS before and 3 months of intervention.

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

    Time frame: Before and 1-, 2- and 3-month intervention.

    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.

  4. Changes in dermatitis family impact (DFI) scores.

    Time frame: Before and 1-, 2- and 3-month intervention.

    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.

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

    Time frame: Before and 1-, 2- and 3-month intervention.

    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.

Sponsors and collaborators

Lead sponsor

Glac Biotech Co., Ltd

Industry

Registry information

Official study title

Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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