Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-27 @ 8:36 AM
Study NCT ID:
NCT06368895
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Efficacy and Safety of Fecal Microbiota Transplantation by Oral Capsules in Patients With Liver
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.
The aims of the study are:
To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.
To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.
To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement.
The aims of the study are:
To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.
To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.
To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement.
Detailed Description:
None
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?: