Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537882
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Evaluate the Effect of Synbiotics on MAFLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Study to Evaluate the Effect of Synbiotics SLP07 on Metabolic Dysfunction-Associated Fatty Liver Disease MAFLD-RCT
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAFLD-RCT
Brief Summary:
Non-alcoholic fatty liver disease NAFLD is one of the most common chronic liver diseases worldwide Available data indicates that probiotics may regulate the gut microbiota while Vitamin E and omega 3 are safe and effective at treating NAFLD patients In this study investigators aim to investigate if the enhanced synbiotic preparation of SLP07 is efficacious in liver function improvement in subjects with MAFLD
Detailed Description:
Non-alcoholic fatty liver disease NAFLD is one of the most common chronic liver diseases worldwide1 The prevalence of NAFLD is estimated to be about 20-30 in the Western world 2 and increasing in Asia The prevalence of NAFLD across Asia varies from 5 to 4034 The population prevalence of NAFLD in Hong Kong Chinese was 2731 NAFLD may progress to non-alcoholic steatohepatitis NASH cirrhosis liver failure and liver cancer and is believed to be the leading etiology for cryptogenic cirrhosis56 NAFLD is also strongly associated with obesity and metabolic syndrome and is shown to be an independent cardiovascular risk factor78 Recently a consensus by an international panel of experts recommended a change in name for NAFLD to metabolic dysfunction associated with fatty liver disease MAFLD9 Patients who fulfil the MAFLD criteria have more severe metabolic and liver disease than those who fulfil the NAFLD criteria alone At present there is no standard pharmacologic therapy available for NAFLD or MAFLD currently
Recently it has been reported that NAFLD might be linked to small intestinal bacterial overgrowth SIBO which induces liver injury by gut-derived lipopolysaccharides LPS and TNF- α production 10 Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD11 Gut microbiota also plays a role in the development of insulin resistance hepatic steatosis necroinflammation and fibrosis 12 The use of probiotics prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota1314 In the meantime Vitamin E has been recommended for use in NAFLD treatmentand prevents liver injury Moreover many clinical trials and meta-analyses have evaluated the efficacy of omega 3 C20-22 ω3 polyunsaturated fatty acids PUFA in reducing existing NAFLD in adults and children and the results indicate that omega 3 is safe and effective at lowering liver fat in NAFLD patients 1516
In this study investigators aim to investigate if the SLP07 which is an investigational product that contains a blend of naturally occurring food-grade Bifidobacterium and Lactobacillus strains omega-3 and vitamin E is efficacious in liver function improvement in subjects with MAFLD
Recently it has been reported that NAFLD might be linked to small intestinal bacterial overgrowth SIBO which induces liver injury by gut-derived lipopolysaccharides LPS and TNF- α production 10 Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD11 Gut microbiota also plays a role in the development of insulin resistance hepatic steatosis necroinflammation and fibrosis 12 The use of probiotics prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota1314 In the meantime Vitamin E has been recommended for use in NAFLD treatmentand prevents liver injury Moreover many clinical trials and meta-analyses have evaluated the efficacy of omega 3 C20-22 ω3 polyunsaturated fatty acids PUFA in reducing existing NAFLD in adults and children and the results indicate that omega 3 is safe and effective at lowering liver fat in NAFLD patients 1516
In this study investigators aim to investigate if the SLP07 which is an investigational product that contains a blend of naturally occurring food-grade Bifidobacterium and Lactobacillus strains omega-3 and vitamin E is efficacious in liver function improvement in subjects with MAFLD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None