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

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The Chinese University of Hong Kong

Status

Enrolling

Conditions

Atopic Eczema

Treatments

Dietary Supplement: SIM05

Study type

Interventional

Funder types

Other

Identifiers

NCT06230991
AEZ-SIM05

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

SIM05
Experimental group
Description:
One sachet twice daily for 16 weeks
Treatment:
Dietary Supplement: SIM05

Trial contacts and locations

1

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Central trial contact

Pui Kuan Cheong, MPH; Yee Ting Fung, BSc

Data sourced from clinicaltrials.gov

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