NCT05286047Completed
Probiotic on Atopic Dermatitis in Infant
Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 9 Mar 2022
- Start date
- 23 Sept 2022
- Primary completion date
- 28 May 2025
- Lead sponsor
- Glac Biotech Co., Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05286047
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 23 Sept 2022 to the primary completion date, 28 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient who has taken oral immunosuppressants and systemic steroids within the past 2 weeks.
- The patient who has received immunotherapy within the past 1 year.
Other illness
- 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 suffering from major diseases (with a IC card for severe illness), congenital diseases.
Other
- 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 is not suitable to participate in the trial as assessed by the professional physician.
Who the study is looking for
- 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.
Age in the registry: 3 months to 3 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Glac Biotech Co., Ltd. Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.