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

March 25, 2025 updated by: Siew Chien NG, Chinese University of Hong Kong

A Pilot Study of Efficacy and Safety of a Microbiome Immunity Formula (SIM05) in Adults with Atopic Eczema

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SIM05
One sachet twice daily for 16 weeks
Dietary supplement: SIM05
SIM05 contains a blend of food-grade Bifidobacterium and Lactobacillus strains plus prebiotics
Other Names:
  • G-NiiB immunity formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eczema Area and Severity Index (EASI) across 16 weeks.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects achieving 50% and 75% reduction in EASI (EASI-50, EASI-75).
Time Frame: 16 weeks
The percentage reduction in EASI score
16 weeks
Change in pruritus numerical rating scales (pruritus-NRS) across 16 weeks.
Time Frame: 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".
16 weeks
Changes in faecal microbial profiling across 16 weeks.
Time Frame: 16 weeks
The changes of profile in faecal microbial
16 weeks
Adverse events reported during the study period.
Time Frame: 16 weeks
The adverse events reported throughout the study
16 weeks
Change in Dermatology life quality index (DLQI) across 16 weeks.
Time Frame: 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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Study Director: Jessica Ching, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

May 21, 2024

Study Completion (Estimated)

December 28, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEZ-SIM05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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