NCT06230991Active, not recruiting
A Pilot Study of Efficacy and Safety of SIM05 in Adults With Atopic Eczema
A Pilot Study of Efficacy and Safety of a Microbiome Immunity Formula (SIM05) in Adults With Atopic Eczema
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
Atopic eczema causes significant disease burdens worldwide. Some studies reported gastrointestinal symptoms in eczema patients which could be related to gut microbiota change. A unique gastrointestinal microflora pattern has also been observed in atopic dermatitis patients when compared with healthy controls. To date, no adult formula is specific for alleviating atopic eczema-related symptoms (especially through change of gut microbiota) for adults. The investigators hypothesize that the gut microbiota of adults with atopic eczema can be modulated to decrease the severity of atopic eczema-related symptoms. A pilot study is proposed to assess the effect and safety of SIM05 on atopic eczema severity and gut microbiome of adults with atopic eczema.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 30 Oct 2023
- Start date
- 10 Oct 2023
- Primary completion date
- 21 May 2024
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06230991
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 10 Oct 2023 to the primary completion date, 21 May 2024
- 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
- Adults with atopic eczema who have taken antibiotics within one months prior to recruitment.
- Adults with atopic eczema who require systemic immunosuppressive treatments (e.g. azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, biologics) within three months prior to recruitment, or who are taking systemic steroids within one month.
Other illness
- Adults with other documented chronic and clinically significant dermatologic diseases that may interfere with the evaluation of cutaneous signs and symptoms. Common conditions such as acne are permissible.
Who the study is looking for
- Adults age 18 or older physician-diagnosed atopic eczema;
- Agree to sign the informed consent form
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.