Clinical trial NCT05286047: Probiotic on Atopic Dermatitis in Infant
Official title: Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Probiotics
Intestinal flora
Allergic diseases
Lead sponsor: Glac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in eczema area and severity index (EASI) scores.
timeFrame: Before and 3 months of intervention.
Secondary outcomes:
measure: Changes in eczema area and severity index (EASI) scores.
timeFrame: After 1 month and 2 months of intervention.
measure: Changes in immune Index (ng/ml).
timeFrame: Before and 3 months of intervention.
measure: Changes in immune Index (pg/ml).
timeFrame: Before and 3 months of intervention.
measure: Changes in gut microbiota ratios.
timeFrame: Before and 3 months of intervention.
measure: Changes in infants' dermatitis quality of life (IDQOL) index.
timeFrame: Before and 1-, 2- and 3-month intervention.
measure: Changes in dermatitis family impact (DFI) scores.
timeFrame: Before and 1-, 2- and 3-month intervention.
measure: Changes in subjects' frequency of medicine use from questionnaires.
timeFrame: Before and 1-, 2- and 3-month intervention.
Other outcomes:
measure: Changes in eczema area and severity index (EASI) scores.
timeFrame: At 2, 4, and 6 months after discontinuation of intervention.
Locations:
city: Tainan City
country: Taiwan
facility: Glac Biotech Co., Ltd.
Study officials:
References: