Table 2 Clinical trials targeting gut-liver axis

From: Gut liver brain axis in diseases: the implications for therapeutic interventions

Classification	Formula	Study status	Disease	Phases	NCT number
Antibiotics	Solithromycin	Completed	NASH	II	NCT02510599
	Rifaximin	Positive⁴³⁸	HE	III	NCT02016196
	Rifaximin	Positive⁴³⁸	HE	IV	NCT02019784
Probiotic	Streptococcus thermophilus, Bifidobacterium and Lactobacillus	Terminated	Fatty Liver	I	NCT00099723
		Positive³³⁰	Obesity	NA	NCT01650025
	Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum	Not yet recruiting	NASH	NA	NCT04781933
	Lactobacillus acidophilus, Lactobacillus casei subsp, Lactobacillus lactis, Bifidobacterium bifidum, Bifidobacterium infantis and Bifidobacterium longum	Unknown	NAFLD	NA	NCT04074889
	Bifidobacterium	Terminated	NAFLD	I/II	NCT04175392
	Lactobacillus acidophilus and Bifidobacterium lactis	Unknown	NAFLD	NA	NCT02764047
	Lactobacillus Lactococcus, Bifidobacterium, Propionibacterium and Acetobacter genera	Completed	NAFLD	NA	NCT03528707
		Completed	NAFLD		NCT03614039
	P. Pentosaceus, L. Lactis or L. Helveticus	Unknown	NAFLD	NA	NCT04555434
	Streptococcus thermophilus, Bifidobacterium and Lactobacillus	Terminated	NASH	I/II	NCT03511365
	-	Positive⁴³⁹	NAFLD	NA	NCT00870012
	Lactobacillus rhamnosus strain GG	Recruiting	NAFLD	NA	NCT04671186
	Lactoplantibacillus plantarum and Levilactobacillus brevis	Completed	NAFLD	NA	NCT04823676
	Lactobacillus reuteri GMNL-263 and GMNL-89 and Lactobacillus rhamnosus GMNL-74	Recruiting	NAFLD	NA	NCT05402449
	Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus rhamnosus and Lactobacillus paracasei	Unknown⁴⁴⁰	NASH	NA	NCT03467282
	Bifidobacterium bifidum and Lactobacillus plantarum 8PA3	Positive⁴⁴¹	ALD	NA	NA
	Lactobacillus casei Shirota	Positive⁴⁴²	ALD	NA	NA
	Lactobacillus subtilis and Streptococcus faecium	Positive⁴⁴³	AH	NA	NA
	Inulin-type fructans	Positive³⁴⁴	Healthy	NA	NCT03042494
	Oligofructose	Positive³⁴³	NASH	NA	NCT03184376
	Inulin and oligofructose	Active not recruiting	NAFLD	NA	NCT02642172
	Prebiotic fiber	Positive⁴⁴⁴	Obesity	NA	NCT02125955
	Prebiotic fiber	Active not recruiting⁴⁴⁵	NAFLD	NA	NCT02568605
	Polyphenols	Positive³⁵⁹	NAFLD	II/III	NCT03380416
Synbiotics	Fructo-oligosaccharides & Bifidobacterium	Negative⁴⁴⁶	NAFLD	NA	NCT01680640
Synbiotics	Fructo-oligosaccharides & Lactobacillus rham- nosus, Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium breve	Positive³⁴⁵	NASH	II/III	NCT01791959
FXR	Obeticholic acid	Positive³⁸⁰	NASH	II	NCT01265498
		Positive³⁷⁹	NASH	III	NCT02548351
		Positive³⁷⁹	NASH	III	EudraCT 20150-025601-6
	EDP-305	Completed	NASH	I	NCT03748628
	EDP-305	Completed³⁸¹	NASH	II	NCT03421431
	MET409	Not recruiting	NASH	II	NCT04702490
	EYP001a	Completed	NASH	I	NCT03976687
	EYP001a	Recruiting	NASH	II	NCT03812029
	Nidufexor	Terminated	NASH	II	NCT02913105
	Tropifexor	Terminated	NASH	II	NCT02855164
	Cilofexor	Positive³⁸²	NASH	II	NCT02854605
	TERN-101	Positive³⁸³	NASH	I	NA
FGF19	Aldafermin	Positive^399,447	NASH	II	NCT02443116
GLP-1	Liraglutide	Positive ^392,393,448	NASH	II	NCT01237119
	ALT-801	Completed	NASH	I	NCT04561245
	Dulaglutide	Not recruiting	NASH	IV	NCT03648554
	Semaglutide	Negative ^395,396	NASH	II	NCT02970942
FMT	A thin and healthy donor	Positive⁴⁴⁹	NAFLD	I/II	NCT02496390
	Lachnospiraceae and Ruminococcaceae donor	Positive ^450,451	HE	I	NCT03152188
	A thin and healthy donor	Negative⁴⁴⁹	Obesity	I/II	NCT02496390
	A thin and healthy donor	Negative⁴⁵²	Obesity	I/II	NCT02530385
	A thin and healthy donor	Positive⁴⁵³	Obesity	I/II	NCT02741518
	A thin and healthy donor	Positive⁴⁵⁴	AH	NA	NA
Polyphenols	Polyphenols	Positive⁴⁵⁵	Obesity	NA	NCT02381145
Polyphenols	Polyphenols	Positive⁴⁵⁵	Obesity	NA	NCT01675401
PUFAs	Omega-3 fatty acids	Completed	NASH	II	NCT01056133
		Completed	NASH	II	NCT00845845
		Negative³⁸⁸	NASH	II/III	NCT00681408

Clinical study status is classified into seven categories: positive, negative, recruiting, not recruiting, completed, terminated, withdrawn, and unknown. Positive indicates the primary endpoint has been reached. Negative indicates that the primary endpoint was not met or that there were substantial adverse effects in the trial. The data is available in Clinical Trials (https://www.clinicaltrials.gov)

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Table 2 Clinical trials targeting gut-liver axis

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