Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496191
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-14
Brief Title:
FMT for Alcohol Use Disorder in Cirrhotics
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
FMT for Alcohol Use Disorder in Cirrhotics A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Title FMT for Alcohol Use Disorder in cirrhotics A Randomized Controlled Trial
The aim of the study is to study the efficacy of Fecal microbiota transplantation in patients with Alcohol liver disease over a 6 month duration without liver related side effects The project will be conducted at ILBS over the period of 1 year
The concept is to test the efficacy of FMT in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality
The aim of the study is to study the efficacy of Fecal microbiota transplantation in patients with Alcohol liver disease over a 6 month duration without liver related side effects The project will be conducted at ILBS over the period of 1 year
The concept is to test the efficacy of FMT in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality
Detailed Description:
Hypothesis - - FMT is useful in reducing craving and return to heavy drinking in patients with alcohol related cirrhosis with active drinking through modulation of gut microbiota and correction of dysbiosis
Aim and Objective -
- To assess the efficacy of FMT in decreasing lapse relapses and maintaining alcohol abstinence in AUD in patients with cirrhosis
Study population
- Patients with cirrhosis with recent alcohol use attending outpatient clinic at ILBS New Delhi
Study design
- Open label parallel group randomized controlled study
Study period
- 1 year
Sample size with justification
- Assuming that abstinence in Placebo group is 50 and we assume that there will be 40 absolute increase in FMT group 90 Bajaj JS Hepatology 2021 with alpha 5 and power of 80 investigator need to enroll 48 cases further assuming 10 dropout rate it was decided to enroll 54 cases that is 27 in each group
Aim and Objective -
- To assess the efficacy of FMT in decreasing lapse relapses and maintaining alcohol abstinence in AUD in patients with cirrhosis
Study population
- Patients with cirrhosis with recent alcohol use attending outpatient clinic at ILBS New Delhi
Study design
- Open label parallel group randomized controlled study
Study period
- 1 year
Sample size with justification
- Assuming that abstinence in Placebo group is 50 and we assume that there will be 40 absolute increase in FMT group 90 Bajaj JS Hepatology 2021 with alpha 5 and power of 80 investigator need to enroll 48 cases further assuming 10 dropout rate it was decided to enroll 54 cases that is 27 in each group
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