GB-EZ-SIM03 Probiotics Study for Childhood Eczema

NCT05607511 | Completed

• 1 other identifier: TG2217044
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Eczema is the most prevalent chronic skin disease in young children, and skin infection is commonly seen during eczema flare. Dysbiosis is increasingly recognised in the stool and skin of these patients. It is a common practice for parents to start these eczematous children on probiotics, but there is limited evidence if this treatment works in young patients. This single-centre, open-label clinical trial aims to investigate the benefits of a 3-month treatment of young children with eczema with a new probiotics called microbiome baby immunity formula (SIM03). Study outcomes include eczema severity, quality of life, biophysical measures of the skin and gastrointestinal symptoms, while adverse events related to this probiotics treatment will be monitored. The effects of this intervention on stool microbiome will also be analysed.

Conditions

Eczema

Keywords

Eczema; Probiotics; Open-label study; Microbiome; Children

Outcome Measures

Primary Outcomes (3)

• Total score for SCORing Atopic Dermatitis (SCORAD)

  Combined endpoint

  3 months

• Stool frequency

  Combined endpoint

  3 months

• Stool consistency

  Combined endpoint

  3 months

Secondary Outcomes (9)

• Subjective SCORAD score

  3 months

• Objective SCORAD score

  3 months

• The change of stool frequency

  3 months

• The change of stool consistency assessed using Bristol Stool Chart

  3 months

• Quality of life assessment using a skin-specific Children's Dermatology Life Quality Index (CDLQI) and Infants' Dermatitis Quality of Life Index (IDQOL)

  3 months

Study Arms (1)

Active probiotics arm

EXPERIMENTAL

The SIM03 (supplied by GenieBiome Limited and produced under Good Manufacturing Practice, GMP) contains a blend of naturally occurring food-grade Bifidobacterium strains (1 billion CFU in 1 sachet). Recruited subjects will receive one sachet of baby immunity formula SIM03 twice daily for 3 months.

Other: Probiotics baby immunity formula (SIM03)

Interventions

Probiotics baby immunity formula (SIM03) OTHER

Daily oral intake of a probiotics sachet

Active probiotics arm

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 to 5 years old with physician-diagnosed eczema according to Hanifin and Rakja criteria \[22,23\];
• One of the parents or legal guardian (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) will provide written informed consent.

You may not qualify if:

• Children with other documented chronic and clinically significant dermatologic diseases, such as erythra, that may interfere with evaluation of cutaneous microbiome. Common transient conditions such as acne are permissible.
• Children with eczema who require systemic immunosuppressive treatments (e.g. corticosteroid, azathioprine, biologics) within six months prior to recruitment.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Paediatrics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masked laboratory staff about the clinical details and disease-related information of participants.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alice Ho Miu Ling Nethersole Charity Foundation Professor of Paediatrics

Model Details: Single-group, open-label interventional clinical trial

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 7, 2022
• Study Start: April 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: February 5, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)