NCT06230991

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Eczema

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SIM05	SIM05 contains a blend of food-grade Bifidobacterium and Lactobacillus strains plus prebiotics

Timeline

• Start date: 2023-10-10
• Primary completion: 2024-05-21
• Completion: 2025-12-28
• First posted: 2024-01-30
• Last updated: 2025-03-28

Locations

1 site across 1 country: Hong Kong