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

NCT06230991 | Active Not Recruiting

• 1 other identifier: AEZ-SIM05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Eczema

Keywords

Atopic Eczema; Gut Microbiota; Probiotics

Outcome Measures

Primary Outcomes (1)

• Change in Eczema Area and Severity Index (EASI) across 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.

  16 weeks

Secondary Outcomes (5)

• Percentage of subjects achieving 50% and 75% reduction in EASI (EASI-50, EASI-75).

  16 weeks

• Change in pruritus numerical rating scales (pruritus-NRS) across 16 weeks.

  16 weeks

• Changes in faecal microbial profiling across 16 weeks.

  16 weeks

• Adverse events reported during the study period.

  16 weeks

• Change in Dermatology life quality index (DLQI) across 16 weeks.

  16 weeks

Study Arms (1)

SIM05

EXPERIMENTAL

One sachet twice daily for 16 weeks

Dietary Supplement: SIM05

Interventions

SIM05 DIETARY_SUPPLEMENT

SIM05 contains a blend of food-grade Bifidobacterium and Lactobacillus strains plus prebiotics

Also known as: G-NiiB immunity formula

SIM05

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (17)

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  BACKGROUND

• Hanifin JM, Baghoomian W, Grinich E, Leshem YA, Jacobson M, Simpson EL. The Eczema Area and Severity Index-A Practical Guide. Dermatitis. 2022 May-Jun 01;33(3):187-192. doi: 10.1097/DER.0000000000000895.

  PMID: 35594457 BACKGROUND

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MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jessica Ching, PhD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All study subjects will receive the same study products.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 30, 2024
• Study Start: October 10, 2023
• Primary Completion: May 21, 2024
• Study Completion: December 28, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)