Fecal microbiota transplantation: A promising treatment strategy for chronic liver disease

Table 2 Ongoing clinical trials of fecal microbiota transplantation in chronic liver diseases from Clinicaltrial.gov

Disease or condition	Study title	Study arms	Intervention	Primary outcomes measures	Clinical trials ID, country
NAFLD, NASH	Fecal microbiota transplantation for the treatment of non-alcoholic steatohepatitis	Lean healthy donor frozen FMT		Efficacy (histological resolution of NASH defined as ballooning disappearance with or without persistence of minimal lobulillar inflammation and no progression of fibrosis stage) (time frame: 72 weeks)	NCT03803540, Spain
NAFLD	Effects of fecal microbiota transplantation on weight in obese patients with non-alcoholic fatty liver disease	Diet + exercise + FMT vs diet + exercise	3 times IMT with 15-day intervals	Proportion of patients achieving ≤ 5% of the weight loss in kg from baseline (time frame: 3 months)	NCT04594954, India
NAFLD	Dietary counseling coupled with FMT in the treatment of obesity and NAFLD-the DIFTOB study	Healthy diet counseling + FMT vs healthy diet counseling + placebo		A change in HOMA-IR (time frame: At week 12 and at week 52)	NCT05607745, Finland
NAFLD with history of diabetes melitus	A prospective, randomized, placebo-controlled pilot study to characterize the intestinal microbiome and to evaluate the safety and fecal microbiome changes following administration of lyophilized PRIM-DJ2727 or placebo given orally for 12 weeks in subjects with NAFLD	Oral PRIM-DJ2727 vs oral placebo	twice weekly for 12 weeks	Microbiome diversity in fecal samples as indicated by the Shannon diversity index (time frame: 10 months)	NCT04371653
NASH	Evaluate the efficacy, safety and tolerability of fecal microbiota transfer for the treatment of patients with nonalcoholic steatohepatitis	Capsules of FMT vs capsules of placebo	An initial dose of 24 oral capsules and a maintenance dose of 12 oral capsules every 3 months for 12 months	Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis (time frame: 72 weeks)	NCT05622526
NASH	Fecal microbiota therapy versus standard therapy in NASH related cirrhosis	FMT vs standard treatment care	Once a month for 5 months	Reduction in hepatic venous pressure gradient in the two groups from baseline (time frame: 1 year)	NCT02721264, India
Alcohol-related liver disease, alcohol use disorder, cirrhosis	Intestinal microbiota transplant in alcohol-associated chronic liver disease and cirrhosis	IMT capsules vs placebo capsules	Twice during the trial	Change in alcohol consumption (time frame: Baseline to 3 months after treatment)	NCT05548452, United States
Liver disease, alcohol dependence, HE and etc.	Safety and efficacy of fecal microbiota transplantation	FMT		The efficacy of FMT in treating dysbiosis-associated disorder will be assessed by number of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome) (time frame: 1 year)	NCT04014413, HongKong, China
SAH	A comparison of fecal microbiota transplantation and steroid therapy in patients with severe alcoholic hepatitis	FMT vs steroids	7 days	Proportion of participants with overall survival at 3 months (time frame: 3 months)	NCT03091010, India
SAH	Fecal microbiota transplantation in severe alcoholic hepatitis- assessment of impact on prognosis and short-term outcome	FMT vs standard of care treatment	1 time	Survival (time frame: 3 months)	NCT03827772, India
AH	Fecal microbiota therapy in steroid ineligible alcoholic hepatitis	FMT vs standard medical treatment	7 times	Mortality at 3 months (time frame: 3 months), liver transplant free survival (time frame: 3 months)	NCT05285592, India
AH	Safety evaluation of fecal microbiota transplantation in severe alcoholic hepatitis	Standard of care + oral PRIM-DJ2727 vs oral placebo	Every day for a week followed by once weekly for 3 weeks	To assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care (time frame: Day 1 to 12 months)	NCT05006430, United States
CHB	Study on effect of intestinal microbiota transplantation in chronic hepatitis B	IMT + antiviral therapy vs antiviral therapy	6 times IMT with 2-week intervals	Change of serum HBeAg level (Time Frame: 1 month, 3 months, 6 months)	NCT03429439, China
HBV induced cirrhosis	Study on effect of intestinal microbiota transplantation in hepatitis B virus induced cirrhosis	Intestinal microbiota transplantation	4 times IMT with 2-week intervals	Change of liver Fibroscan score (time frame: 3 months, 6 months, 12 months)	NCT03437876, China
Acute-on-chronic liver failure, hepatitis B	Efficacy of addition of FMT and plasma exchange to tenofovir in comparison to monotherapy with tenofovir in ACLF-HBV	Plasma exchange + tenofovir + FMT vs tenofovir	7 days	Overall survival in both groups (time frame: Day 28)	NCT04431375, India
Decompensated cirrhosis	Fecal microbiota transplantation for decompensated cirrhosis	FMT + traditional treatment vs traditional treatment		Number of adverse events complication rate in all patients in both groups (time frame: 3 months)	NCT03014505, Chian
Cirrhosis, liver	Fecal microbiota transplantation in cirrhosis	FMT vs control		Blood ammonia, ALT, AST, gut microbiome, albumin, blood glucose, serum creatinine, direct bilirubin, indirect bilirubin, prothrombin time activity percentage and liver stiffness (time frame: Change from baseline, at 12 months)	NCT04591522
Cirrhosis of the liver	Trial of faecal microbiota transplantation in cirrhosis	FMT vs placebo		Assessment of the feasibility of FMT (time frame: 18 months)	NCT02862249, United Kingdom
Liver cirrhosis	Faecal microbiota transplantation for liver cirrhosis	FMT vs placebo	3 times	Time to death or readmission due to episode of acute decompensation in FMT treated vs placebo treated patients (Time Frame: 1 year)	NCT04932577, Denmark
Cirrhosis, HE	FMT in cirrhosis and hepatic encephalopathy	Dual oral and rectal FMT vs oral FMT and rectal placebo vs oral placebo and rectal FMT vs oral and rectal placebo		Adverse events related to FMT (time frame: 6 months), change in microbial diversity in stool (time frame: 6 months)	NCT03796598, United States
HE	Fecal microbiota transplant as treatment of hepatic encephalopathy	FMT oral capsules vs placebo oral capsule	days 1, 2, 7, 14, and 21	PHES [time frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)]	NCT03420482, United States
HE	Efficacy and safety of fecal microbiota transplant for secondary prophylaxis of hepatic encephalopathy	FMT + standard medical therapy vs standard medical therapy	3 times	Proportion of patients developing an episode of hepatic encephalopathy within 6 months (time frame: 6 months)	NCT05229289, India

ACLF: Acute on chronic liver failure; AH: Alcoholic hepatitis; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; CHB: Chronic hepatitis B; FMT: Fecal microbiota transplantation; HBeAg: Hepatitis B e antigen; HBV: Hepatitis B virus; HE: Hepatic encephalopathy; HOMA-IR: Homeostasis model assessment of Insulin Resistance; MRI: Magnetic resonance imaging; NAFLD: Non-alcoholic fatty liver disease; NASH: Non-alcoholic steatohepatitis; PHES: Psychometric Hepatic Encephalopathy Score; SAH: Severe alcoholic hepatitis.