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

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 valuea,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	< 0.001a	-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	0.009a	-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	< 0.001a	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	< 0.001a	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	0.044a	-2.52 ± 1.24	0.044a
LTT	97.7 ± 20.7	76.9 ± 16.9	< 0.001	97.7 ± 20.7	78.3 ± 22.4	< 0.001a	-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	< 0.001a	15.07 ± 27.69	0.590
Role limitation physical health	193 ± 140	290 ± 134	0.005	161 ± 130	302 ± 124	< 0.001a	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	0.005a	-11.23 ± 8.27	0.180
Emotional well-being	345 ± 33	363 ± 25	0.003	338 ± 38	359 ± 31	0.004a	-4.76 ± 5.62	0.400
Social functioning	164 ± 33	186 ± 23	0.001	166 ± 33	179 ± 25	0.018a	-7.58 ± 4.76	0.120
Pain	150 ± 29	183 ± 22	< 0.001	148 ± 24	175 ± 25	< 0.001a	-8.86 ± 4.64	0.059
General health	241 ± 47	276 ± 41	0.001	229 ± 39	284 ± 36	< 0.001a	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.