Probiotic on Atopic Dermatitis in Infant

Atopic Dermatitis Clinical Trial

Official title:

Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286047
• Other study ID #: CMUH-2021001
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Glac Biotech Co., Ltd
• Contact: Hung-Chih Lin, M.D., Ph.D
• Phone: 886-4-22052121
• Email: d0373[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical trial will be carried out in China Medical University Hospital. The overall plan is a double-blind trial. All recruited 1-3 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 nine months. The number of probiotic bacteria is 50 billion per capsule, and the number of bacteria taken by the subjects is 50 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 three month, and the score differences of dermatitis before and after taking probiotics was observed. Three months before and after blood tests for IgE, ECP, TSLP, IFN-γ, IL-4, IL-5, IL-13, TNF-α, CCL5(RANTES), TGF-β, IL-1ra, and evaluation of probiotic supplementation, whether that can reduce allergies and inflammatory indexes in the body. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: June 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

• Subjects were between 1 and 3 years old.
• For patients diagnosed with atopic dermatitis by a professional physician and the EASI score is greater than 10, 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Bifidobacterium longum CCFM1029
Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime.
• Placebo
Subjects take one capsule containing maltodextrin daily at bedtime.

Locations

Country	Name	City	State
Taiwan	Glac Biotech Co., Ltd.	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
Glac Biotech Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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 months of intervention.
Secondary	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.
Secondary	Changes in immune Index (ng/ml).	Changes in IgE and ECP were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in immune Index (pg/ml).	Changes in TSLP?IFN-??IL-4?IL-5?IL-13?TNF-a?CCL5(RANTES)?TGF-ß and IL-1ra (pg/ml) were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.