NCT05607511Completed
GB-EZ-SIM03 Probiotics Study for Childhood Eczema
Improvement in Eczema and the Safety of Microbiome Baby Immunity Formula (SIM03) on Childhood Eczema Development - A Pilot Study
Source: ClinicalTrials.gov · Last updated 8 Feb 2024
Brief summary (registry, in English)
Eczema is the most prevalent chronic skin disease in young children, and skin infection is commonly seen during eczema flare. Dysbiosis is increasingly recognised in the stool and skin of these patients. It is a common practice for parents to start these eczematous children on probiotics, but there is limited evidence if this treatment works in young patients. This single-centre, open-label clinical trial aims to investigate the benefits of a 3-month treatment of young children with eczema with a new probiotics called microbiome baby immunity formula (SIM03). Study outcomes include eczema severity, quality of life, biophysical measures of the skin and gastrointestinal symptoms, while adverse events related to this probiotics treatment will be monitored. The effects of this intervention on stool microbiome will also be analysed.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 28 Oct 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 31 Oct 2022
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05607511
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Apr 2022 to the primary completion date, 31 Oct 2022
- 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children with eczema who have taken antibiotics, probiotics or prebiotics in supplement, including but not limited to growing-up milk formula and infant's supplementary food within three months prior to inclusion.
- Children with eczema who require systemic immunosuppressive treatments (e.g. corticosteroid, azathioprine, biologics) within six months prior to recruitment.
Other illness
- Children with other documented chronic and clinically significant dermatologic diseases, such as erythra, that may interfere with evaluation of cutaneous microbiome. Common transient conditions such as acne are permissible.
Who the study is looking for
- Children aged 1 to 5 years old with physician-diagnosed eczema according to Hanifin and Rakja criteria \[22,23\];
- One of the parents or legal guardian (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) will provide written informed consent.
Age in the registry: 1 year to 5 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Paediatrics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.