Impact of two-session fecal microbiota transplantation on minimal hepatic encephalopathy in cirrhosis

doi:10.4254/wjh.v18.i4.116153

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Apr 27, 2026 (publication date) through May 12, 2026

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World Journal of Hepatology

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1948-5182

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Controlled Trial

Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Hepatol. Apr 27, 2026; 18(4): 116153
Published online Apr 27, 2026. doi: 10.4254/wjh.v18.i4.116153

Table 1 Baseline characteristics of the patients

Characteristics	Overall population (n = 122)	FMT (n = 60)	Lactulose (n = 62)
Age (years)	44.3 ± 8.9	43.7 ± 9.1	44.8 ± 8.9
Sex (male)	118 (96.7)	57 (95.0)	61 (98.4)
BMI (kg/m²)	23.6 (21.9-25.8)	23.4 (21.2-25.9)	23.8 (22.1-25.8)
Education (formal education in years)	11.4 ± 3.4	11.3 ± 3.1	11.5 ± 3.7
Etiology
Alcohol	67 (54.9)	32 (53.3)	35 (56.4)
MASLD	22 (18.0)	9 (15.0)	13 (21.0)
Hepatitis B	25 (20.5)	15 (25.0)	10 (16.1)
Hepatitis C	8 (6.6)	4 (6.7)	4 (6.5)
Hemoglobin (g/dL)	11.1 (9.4-12.6)	11.5 (10.12-12.85)	10.8 (9.12-12.1)
TLC (mm³)	5500 (4400-7350)	6030 (5105-8655)	5290 (4090-6150)
Platelet count (× 10³/mm³)	98 (66-128)	99 (68-137)	97 (65-118)
Total bilirubin (mg/dL)	2.0 (1.3-2.6)	2.1 (1.3-2.9)	1.7 (1.1-2.4)
AST (U/L)	64 (45-98)	66 (47-106)	64 (41-92)
ALT (U/L)	35 (25-49)	36 (24-51)	33 (26-45)
ALP (U/L)	139 (107-186)	140 (109-186)	139 (107-208)
Total protein (g/dL)	7.9 (7.4-8.2)	7.9 (7.3-8.2)	7.9 (7.5-8.3)
Albumin (g/dL)	3.5 ± 0.7	3.4 ± 0.7	3.6 ± 0.7
Urea (mg/dL)	22 (16-32)	25 (16-34)	20 (16-28)
Creatinine (mg/dL)	0.9 ± 0.2	0.9 ± 0.2	0.9 ± 0.2
Sodium (mEq/L)	136.0 ± 4.6	136.1 ± 4.2	135.9 ± 4.9
Potassium (mEq/L)	4.4 ± 0.5	4.3 ± 0.6	4.5 ± 0.5
INR	1.5 (1.3-1.8)	1.6 (1.3-1.8)	1.4 (1.3-1.8)
AFP	4.3 (2.7-5.8)	4.5 (2.7-5.8)	3.7 (2.68-6.0)
CTP class
A	39 (32.0)	15 (25.0)	24 (38.7)
B	65 (53.3)	33 (55.0)	32 (51.6)
C	18 (14.6)	12 (20.0)	6 (9.7)
ANT	12.4 ± 2.3	12.7 ± 2.2	12.0 ± 2.4
LSM (kPa)	40.1 (26.6-60.2)	37.3 (28.0-58.6)	43.3 (26.0-64.7)
CAP (dB/m)	224 (193-249)	223 (196-242)	226 (190-259)
Ammonia	86 (72-107)	87 (66-107)	84 (74-105)
CTP score	7.0 (6.0-9.0)	7.0 (6.5-9.0)	7.0 (6.0-9.0)
MELD	13 (10-17)	14 (11-17)	13 (10-16)
MELD-Na	15.4 ± 4.5	15.7 ± 4.5	15.2 ± 4.5

Note all data are presented as n (%), median or mean ± SD.

FMT: Fecal microbiota transplantation; BMI: Body mass index; MASLD: Metabolic dysfunction-associated liver disease; TLC: Total leucocyte count; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; ALP: Alkaline phosphatase; INR: International normalised ratio; AFP: Alpha-fetoprotein; CTP: Child-Turcotte-Pugh score; ANT: Animal naming test; LSM: Liver stiffness measurement; CAP: Controlled attenuation parameter; MELD: Model for end-stage liver disease.

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Table 2 Effect of fecal microbiota transplantation and Lactulose on clinical outcomes and neuropsychological test results

Outcomes	FMT baseline (n = 60)	FMT 3 months (n = 60)	P value^a^,¹	Lactulose baseline (n = 62)	Lactulose 3-month (n = 62)	P value²	Intergroup difference³ (adjusted mean difference ± standard error) [adjusted risk difference (95% confidence interval)]	P value⁴
Primary outcome
Resolution of MHE	-	41 (68.3%)	-	-	41 (66.1%)	-	2.2% (-14.4% to 18.9%)	0.800
Secondary outcomes
Overt HE	-	2 (3.3%)	-	-	1 (1.6%)	-	-1.7% (-7.2% to 3.8%)	1.000
MELD-Na score	15.7 ± 4.5	14.9 ± 4.3	0.18	15.2 ± 4.5	13.7 ± 4.3	0.06	-0.89 ± 0.35	0.250
CTP score	7.9 ± 1.5	7.2 ± 1.5	< 0.001	7.4 ± 1.4	7.2 ± 1.5	0.22	0.32 ± 0.22	0.150
Ammonia	89 ± 30	85 ± 27	0.351	89 ± 26	82 ± 22	0.109	-0.9 ± 12.5	0.950
PHES score	-6.1 ± 1.2	-3.3 ± 1.8	< 0.001	-6.1 ± 1.2	-3.2 ± 1.5	< 0.001^a	-0.12 ± 0.31	0.710
PHES individual components
NCT-A	89.6 ± 25.4	78.0 ± 17.1	0.065	93.4 ± 28.3	80.1 ± 20.0	0.009^a	-2.08 ± 3.61	0.570
FCT	79.2 ± 20.7	62.4 ± 15.8	< 0.001	79.2 ± 20.7	58.4 ± 15.7	< 0.001^a	3.76 ± 2.99	0.210
SDT	61.0 ± 10.5	50.9 ± 7.8	< 0.001	61.0 ± 10.5	50.6 ± 9.4	< 0.001^a	0.34 ± 1.66	0.840
DST	17.4 ± 4.3	22.3 ± 7.8	< 0.001	17.4 ± 4.3	20.2 ± 5.0	0.044^a	-2.52 ± 1.24	0.044^a
LTT	97.7 ± 20.7	76.9 ± 16.9	< 0.001	97.7 ± 20.7	78.3 ± 22.4	< 0.001^a	-0.60 ± 3.73	0.870
Health-related Quality of Life (SF-36) domains
Physical functioning	657 ± 183	783 ± 145	0.001	637 ± 193	798 ± 136	< 0.001^a	15.07 ± 27.69	0.590
Role limitation physical health	193 ± 140	290 ± 134	0.005	161 ± 130	302 ± 124	< 0.001^a	7.36 ± 25.69	0.780
Role limitation and mental health	237 ± 84	280 ± 46	0.007	242 ± 82	260 ± 78	0.250	-19.64 ± 12.85	0.130
Energy/fatigue	188 ± 40	217 ± 42	0.002	185 ± 39	206 ± 42	0.005^a	-11.23 ± 8.27	0.180
Emotional well-being	345 ± 33	363 ± 25	0.003	338 ± 38	359 ± 31	0.004^a	-4.76 ± 5.62	0.400
Social functioning	164 ± 33	186 ± 23	0.001	166 ± 33	179 ± 25	0.018^a	-7.58 ± 4.76	0.120
Pain	150 ± 29	183 ± 22	< 0.001	148 ± 24	175 ± 25	< 0.001^a	-8.86 ± 4.64	0.059
General health	241 ± 47	276 ± 41	0.001	229 ± 39	284 ± 36	< 0.001^a	7.84 ± 7.72	0.312

^aP < 0.05.

¹Difference between pre and post fecal microbiota transplantation scores at baseline and 3 months, respectively.

²Difference between pre and post lactulose scores at baseline and 3 months respectively.

³Final observation at 3 months is compared between the two treatment groups adjusted for respective baseline parameters. minimal hepatic encephalopathy is given as an adjusted risk difference. Positive values indicate a higher value in the lactulose group and vice versa.

⁴Intergroup difference adjusted for baseline.

FMT: Fecal microbiota transplantation; MHE: Minimal hepatic encephalopathy; HE: Hepatic encephalopathy; MELD: Model for end-stage liver disease; CTP: Child-Turcotte-Pugh score; PHES: Psychometric hepatic encephalopathy score; NCT-A: Number connection test; FCT: Figure connection test; SDT: Serial-dotting test; DST: Digit symbol test; LTT: Line-tracing test; SF-36: The 36-item short form survey.

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Table 3 Adverse events over 3 months follow-up, n (%)

	Overall (n = 122)	FMT (n = 60)	Lactulose (n = 62)	P value
Any adverse events¹	58 (47.5)	32 (53.3)	26 (41.9)	0.21
Bloating	18 (14.8)	3 (5.0)	15 (24.2)	< 0.01
Abdominal pain	16 (13.1)	7 (11.7)	9 (14.5)	0.64
Diarrhoea	11 (9.0)	6 (10.0)	5 (8.1)	0.71
Vomiting	4 (3.3)	3 (5.0)	1 (1.6)	0.36
Malaise	9 (7.4)	7 (11.7)	2 (3.2)	0.09
Fever	17 (13.9)	12 (20.0)	5 (8.1)	0.06
Cough	3 (2.5)	3 (5.0)	0	0.12
Constipation	7 (5.7)	7 (11.7)	0	< 0.01
Altered taste	1 (0.8)	1 (1.7)	0	0.49
Death	3 (2.5)	2 (3.3)	1 (1.6)	0.62
Overt HE	3 (2.5)	2 (3.3)	1 (1.6)	1.00
Sepsis	7 (5.7)	5 (8.3)	2 (3.2)	0.13
Pneumonia	2 (1.6)	2 (3.3)	0
Urosepsis	2 (1.6)	1 (1.7)	1 (1.6)
Cellulitis	1 (0.8)	0	1 (1.6)
Gastrointestinal	2 (1.6)	2 (3.3)	0

¹Total number of adverse events may not be additive, as a single patient may experience more than one event.

FMT: Fecal microbiota transplantation; HE: Hepatic encephalopathy.

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Citation: Agarwal A, Agrawal S, Talukdar D, Kaur M, Biswas S, Swaroop S, Golla R, Kandiyal B, Jana P, Tanwar S, Aggarwal A, Singh HC, Agarwal A, Mahajan M, Tiwari B, Nayak B, Goel A, Das B, Shalimar. Impact of two-session fecal microbiota transplantation on minimal hepatic encephalopathy in cirrhosis. World J Hepatol 2026; 18(4): 116153
URL: https://www.wjgnet.com/1948-5182/full/v18/i4/116153.htm
DOI: https://dx.doi.org/10.4254/wjh.v18.i4.116153

Agarwal A, Agrawal S, Talukdar D, Kaur M, Biswas S, Swaroop S, Golla R, Kandiyal B, Jana P, Tanwar S, Aggarwal A, Singh HC, Agarwal A, Mahajan M, Tiwari B, Nayak B, Goel A, Das B, Shalimar. Impact of two-session fecal microbiota transplantation on minimal hepatic encephalopathy in cirrhosis. World J Hepatol 2026; 18(4): 116153 [DOI: 10.4254/wjh.v18.i4.116153]

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