Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230991
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-10-30
Brief Title:
A Pilot Study of Efficacy and Safety of SIM05 in Adults With Atopic Eczema
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Pilot Study of Efficacy and Safety of a Microbiome Immunity Formula SIM05 in Adults With Atopic Eczema
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None