Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781933
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2021-02-17
Brief Title:
Interest in Combo a Combination of Dietary Supplements Including Probiotics in NASH Improvement
Sponsor:
Mativa-Tech SA
Organization:
Mativa-Tech SA
Study Overview
Official Title:
Interest in Combo a Combination of Dietary Supplements Including Probiotics in NASH Improvement
Status:
RECRUITING
Status Verified Date:
2023-11
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:
ICAN
Brief Summary:
The aim of this bicentre prospective placebo-controlled double-blind randomized interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis NASH patients with mild or severe fibrosis
Detailed Description:
Liver-related mortality is increased 10-fold in NASH patients compared with the general population Currently there are no established pharmacotherapies for NASH patients The gut microbiota has a major contributing role in the development of NASH with leaky gut inflammation oxidative stress and impaired microbiota Restoring the microbiota symbiosys could be a new way of resolution of NASH
The aim of this trial is to evaluate the efficacy of the Combo association of probiotics Lactobacillus rhamnosus GG Bifidobacterium breve BR03 Lactobacillus plantarum and Glutamine Quercetin Vitamin E Curcumin Silybin Pectin by means of histological resolution of NASH without progression of fibrosis after 26 weeks 6 months in 60 NASH patients with mild to severe fibrosis
To confirm a histological diagnosis of NASH and proof efficacy of the Combo a liver biopsy will be performed prior to screening as well as at the end of supplemental phase
The aim of this trial is to evaluate the efficacy of the Combo association of probiotics Lactobacillus rhamnosus GG Bifidobacterium breve BR03 Lactobacillus plantarum and Glutamine Quercetin Vitamin E Curcumin Silybin Pectin by means of histological resolution of NASH without progression of fibrosis after 26 weeks 6 months in 60 NASH patients with mild to severe fibrosis
To confirm a histological diagnosis of NASH and proof efficacy of the Combo a liver biopsy will be performed prior to screening as well as at the end of supplemental phase
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