Atopic DermatitisNCT05286047
Probiotic on Atopic Dermatitis in Infant
A study testing Bifidobacterium longum CCFM1029 in people with Atopic Dermatitis, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Bifidobacterium longum CCFM1029
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2022to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Bifidobacterium longum CCFM1029, Placebo
- Keywords
- Atopic dermatitis, Probiotics, Intestinal flora, Allergic diseases
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longum CCFM1029Dietary supplement
Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime.
PlaceboDietary supplement
Subjects take one capsule containing maltodextrin daily at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium longum CCFM1029 | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium longum CCFM1029 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and 3-month intervention.
Secondary outcomes (5)
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.
Measured: After 1 month and 2 months of intervention.
Changes in gut microbiota ratios.
Changes in gut microbiota ratios were assessed by NGS before and 3 months of intervention.
Measured: Before and 3 months of intervention.
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.
Measured: Before and 1-, 2- and 3-month intervention.
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.
Measured: Before and 1-, 2- and 3-month intervention.
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.
Measured: Before and 1-, 2- and 3-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start23 Sep 2022
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286047
- Sponsor's protocol ID
- CMUH-2021001
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Bifidobacterium Longum CCFM1029 on Atopic Dermatitis in Infant
- ClinicalTrials.gov ID
- NCT05286047
- Acronym / sponsor ID
- CMUH-2021001
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Probiotics, Intestinal flora, Allergic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Glac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium longum CCFM1029 | Experimental | Dietary Supplement: Bifidobacterium longum CCFM1029 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium longum CCFM1029Subjects take one capsule containing Bifidobacterium longum CCFM1029 daily at bedtime. | Dietary supplement | Bifidobacterium longum CCFM1029 |
| PlaceboSubjects take one capsule containing maltodextrin daily at bedtime. | Dietary supplement | Placebo |
Primary outcome
Changes in eczema area and severity index (EASI) scores.
Time frame: Before and 3-month intervention.
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.
5 secondary outcomes
Changes in eczema area and severity index (EASI) scores.
Time frame: After 1 month and 2 months of intervention.
Changes in gut microbiota ratios.
Time frame: Before and 3 months of intervention.
Changes in infants' dermatitis quality of life (IDQOL) index.
Time frame: Before and 1-, 2- and 3-month intervention.
Changes in dermatitis family impact (DFI) scores.
Time frame: Before and 1-, 2- and 3-month intervention.
Changes in subjects' frequency of medicine use from questionnaires.
Time frame: Before and 1-, 2- and 3-month intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum CCFM1029 in people with Atopic Dermatitis, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in eczema area and severity index (EASI) scores. (time frame: Before and 3-month intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.