Atopic Dermatitis
Conditions
Interventions
Probiotic group:Received pharmacological intervention combined with Bifidobacterium longum subspecies Dipro-017 preparation intervention
Placebo group:Received drug intervention combined with placebo intervention
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. The subject's parent/legal guardian must provide a signed and dated informed consent form; 2. At the time of signing the informed consent, the subject (male or female) must be 3–6 years old; 3. Gestational age must be between 37–42 weeks, with a birth weight of 2500 g–4000 g; 4. During the screening period, the subject must be confirmed to have atopic dermatitis (AD) according to the modified Hanifin & Rajka AD diagnostic criteria, with a cumulative AD history of more than 6 months; 5. At screening, the Investigator’s Global Assessment (IGA) score must be <=3, the Eczema Area and Severity Index (EASI) score must be <=21, and the Body Surface Area (BSA) affected by AD lesions (excluding scalp lesions but including facial lesions) must be <=10%; 6. The subject must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Diseases that may interfere with the evaluation of study results, such as immune dysfunction, severe renal or hepatic dysfunction, severe cardiovascular diseases, malignant tumors, and acute or chronic infections; 2. Use of other probiotic preparations (including the probiotic strains used in this study), antibiotics, oral and/or topical hormones, immunosuppressants, biologics, or JAK inhibitors within 4 weeks prior to participating in the study; 3. Confirmed parasitic infection that is uncontrolled; 4.(1) Patients with chronic diseases currently undergoing medication; (2) Individuals with severe organic pathologies of the thyroid, heart, brain, lungs, kidneys, or motor system; (3) Those suffering from mental illnesses or with a history of mental disorders; (4) Long-term users of glucocorticoids; (5) Users of growth hormone, gamma-aminobutyric acid, or lysine-inositol vitamin B12; 5. Any uncontrolled clinically significant laboratory abnormality deemed by the investigator as potentially affecting the interpretation of study data or the subject's participation in the study; 6. Participation in other clinical intervention studies involving drugs, dietary supplements, other probiotics, or prebiotics within the past 3 months; 7. Suffering from severe infections or severe trauma as determined by the investigator, or having undergone major or moderate surgery within the past month; 8. Known allergy to any product ingredients; 9. The investigator considers the subject unsuitable to participate in this clinical study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atopic Dermatitis Severity Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota;Gut metabolites;Gut immune markers;Allergy Symptom Questionnaire Score;Quality of Life Questionnaire Score; | — |
Countries
China
Contacts
Public ContactJinrong Zeng
The Third Xiangya Hospital of Central South University
Outcome results
None listed