A Pilot Study of Efficacy and Safety of SIM05 in Adults With Atopic Eczema

Not Applicable

Active, not recruiting

• Conditions: Atopic Eczema
• Interventions: Dietary Supplement: SIM05

• Registration Number: NCT06230991
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-01-30
• Primary Completion: 2024-05-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIM05	SIM05	One sachet twice daily for 16 weeks

Primary Outcome Measures

Name	Time	Method
Change in Eczema Area and Severity Index (EASI) across 16 weeks.	16 weeks	The change of score in Eczema Area and Severity Index. A score of 0 indicates clear or no eczema, 0.1 to 1.0 indicates almost clear, 1.1 to 7 indicates mild disease, 7.1 to 21 indicates moderate disease, 21.1 to 50 indicates severe disease, and greater than 51 indicates very severe disease.

Secondary Outcome Measures

Name	Time	Method
Change in Dermatology life quality index (DLQI) across 16 weeks.	16 weeks	The change of quality of life measuring in DLQI scales. The scoring of each question is 'very much = 3'; 'quite a lot = 2'; 'only a little = 1' and 'not at all = 0'. The meaning of scores: 0-1 = no effect on life; 2-6 = small effect; 7-12 = moderate effect; 13-18 = very large effect and 19-30 = extremely large effect.
Adverse events reported during the study period.	16 weeks	The adverse events reported throughout the study
Percentage of subjects achieving 50% and 75% reduction in EASI (EASI-50, EASI-75).	16 weeks	The percentage reduction in EASI score
Changes in faecal microbial profiling across 16 weeks.	16 weeks	The changes of profile in faecal microbial
Change in pruritus numerical rating scales (pruritus-NRS) across 16 weeks.	16 weeks	The change of quality of life measuring in pruritus-NRS. On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong