Probiotic treatment for infants with atopic dermatitis
Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant
NA · Glac Biotech Co., Ltd · NCT05286047
This study is testing if a probiotic can help reduce eczema symptoms in infants aged 1 to 3 years who have atopic dermatitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 3 Years |
| Sex | All |
| Sponsor | Glac Biotech Co., Ltd (industry) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tainan City) |
| Trial ID | NCT05286047 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the probiotic Bifidobacterium longum CCFM1029 on infants aged 1 to 3 years diagnosed with atopic dermatitis. The study is designed as a double-blind trial, where participants are randomly assigned to receive either the probiotic or a placebo for a duration of nine months. The primary outcome measures include changes in the eczema area and severity index (EASI) scores, as well as various blood markers related to allergies and inflammation. Evaluations will occur every three months to assess the efficacy of the probiotic in reducing symptoms and inflammatory responses associated with atopic dermatitis.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 1 to 3 years with a confirmed diagnosis of atopic dermatitis and an EASI score greater than 10.
Not a fit: Patients with a history of allergic reactions or those who have recently used immunosuppressants or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of atopic dermatitis in infants, potentially reducing symptoms and the need for more invasive therapies.
How similar studies have performed: While the use of probiotics in treating atopic dermatitis is a growing area of interest, this specific approach with Bifidobacterium longum CCFM1029 is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tainan City
- Glac Biotech Co., Ltd. — Tainan City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hung-Chih Lin, M.D., Ph.D
- Email: d0373@mail.cmuh.org.tw
- Phone: 886-4-22052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atopic Dermatitis, Atopic dermatitis, Probiotics, Intestinal flora, Allergic diseases