Clinical trial NCT06230991: A Pilot Study of Efficacy and Safety of SIM05 in Adults With Atopic Eczema
Official title: A Pilot Study of Efficacy and Safety of a Microbiome Immunity Formula (SIM05) in Adults With Atopic Eczema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atopic Eczema
Keywords: Atopic Eczema
Gut Microbiota
Probiotics
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study subjects will receive the same study products.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The major atopic disorders, atopic eczema, allergic rhinitis and asthma, cause significant disease burdens worldwide.

Apart from cutaneous symptoms such as dryness and itchiness in eczema patients \[4\], studies also reported gastrointestinal symptoms which could be related to gut microbiota change. Unique gastrointestinal microflora pattern has also been observed in atopic dermatitis patients when compared with healthy controls: decreased Bifidobacterium and Enterococci, especially Bifidobacterium bifidum and Bifidobacterium longum, and increased Faecalibacterium have been observed. Therefore, gastrointestinal microflora can serve as the disease indicator of atopic eczema. Emerging evidence also suggests that gut microbiota modulation can largely affect host immune functions in adults.

To date, no adult formula is specific for alleviating atopic eczema-related symptoms (especially through change of gut microbiota) for adults. SIM05 contains a blend of naturally occurring three food-grade probiotics strains and three prebiotics. The three probiotics belong to food-grade Bifidobacterium and Lactobacillus, which is an important group of probiotic cultures commonly used in food products. Moreover, research showed that Lactobacillus and Bifidobacteria could prevent atopic sensitisation to common food allergens and thus reducing the incidence of atopic eczema.

The investigators hypothesize that the gut microbiota of adult with atopic eczema can be modulated to decrease the severity of atopic eczema related symptoms. A pilot study of 30 adults with atopic eczema who will receive SIM05 for 16 weeks is proposed to assess the effect and safety of SIM05 on atopic eczema severity and gut microbiome.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 or older physician-diagnosed atopic eczema;
* Agree to sign the informed consent form

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in Eczema Area and Severity Index (EASI) across 16 weeks.
timeFrame: 16 weeks
Secondary outcomes:
measure: Percentage of subjects achieving 50% and 75% reduction in EASI (EASI-50, EASI-75).
timeFrame: 16 weeks
measure: Change in pruritus numerical rating scales (pruritus-NRS) across 16 weeks.
timeFrame: 16 weeks
measure: Changes in faecal microbial profiling across 16 weeks.
timeFrame: 16 weeks
measure: Adverse events reported during the study period.
timeFrame: 16 weeks
measure: Change in Dermatology life quality index (DLQI) across 16 weeks.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Jessica Ching, PhD
role: STUDY_DIRECTOR
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