Table 2.
Study | Aetiology | Sample Size | Patients Characteristics | FMT Type | Donors | Main Objective | Secondary Aim |
---|---|---|---|---|---|---|---|
Allegretti JR. 2019 [81] | PSC | 10 | No cirrhosis, 9 UC and 1 CD, only with mesalamine or azathioprine, and 4-week washout period for UDCA |
By colonoscopy 90 mL bowel preparation with polyethylene glycol on the day before. |
A single healthy donor | Safety: no adverse events related to FMT. | 30% experienced a decrease in ALP ≥ 50% during the 24 weeks. Early changes in diversity as from first week that were maintained to 24 weeks. Increase in short-chain fatty acid producing genera. Correlation between the abundance of engrafter OTUs and a decrease in ALP Levels. No changes in stool bile acid profile clustering. |
Bajaj J. 2021 [82] | AUD | 20 | Cirrhosis with a MELD score of 8.9 points | Placebo or FMT enema 1:1 (90 mL, 27 g stool, 2.7 × 1012 CFU) | OpenBiome where donor selection was performed to maximize Lachnospiraceae and Ruminococcaceae, which were lacking in the patients | Safety: 2 patients in FMT group had an adverse event but FMT-unrelated | Reduction of craving in 90%, psychosocial QOL improved and reduction in urinary EtG/creatinine. Reduction in systemic inflammation (IL-6) and in intestinal permeability (lower LBP). Microbial diversity increased with higher Ruminococcaceae and other SCFA producing taxa. |
Bajaj J. 2017 [61] | Several | 20 | Cirrhotic with recurrent HE (at least two overt HE episodes requiring therapy), MELD < 17 and no active alcohol abuse. | 5 days of antibiotics prior to FMT enema (Three frozen-then-thawed FMT units; 90 mL); Lactulose and rifaximin were continued. | 1 donor with the optimal microbiota deficient in HE (Lachnospiraceae and Ruminococcacea) | Safety: at 150 days, 2 patients (20%) in FMT group had an adverse event but FMT-unrelated. | No FMT patients developed further HE in 5 months follow up vs. 50% in SOC. Improvement in PHES total score and EncephalApp Stroop. Increase in diversity and beneficial taxa (Lactobacillaceae, Bifidobacteriaceae, Lachnospiraceaeae and Ruminococcaceae). MELD score transiently worsened post-antibiotics. |
Bajaj J. 2019 [85] | Several | 20 | Cirrhotic outpatients with recurrent HE | 5 days of pre-FMT antibiotics 90 mL enema containing 2.7 × 1012 CFU | A single donor: rich in Lachnospiraceae and Ruminococcaceae | Well-tolerated. | Reduced need for hospitalization and HE episodes. Increase in diversity and increase in relative abundance of Burkholderiaceae and decreased Acidaminoccocaceae but not in Lachnospiraceae and Ruminococcaceae. |
Bajaj J. 2019 [77] | Several | 20 | Cirrhotic patients with recurrent HE with MELD < 17. | 15 FMT capsules (4.125 g stool) at once vs. placebo No pre-antibiotic therapy |
A single donor rich in Lachnospiraceae and Ruminococcaceae | Safe and well-tolerated. | One patient had an HE (related to TIPS) vs. 3 patients in SOC (1 of them 5 episodes). No differences in stool diversity at day 30. Post-FMT, duodenal mucosal diversity increased with higher Ruminococcaceae, Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae. Reduction in Veillonellaceae was seen post-FMT in sigmoid and stool. IL-6 and serum LBP reduced post-FMT. |
Bajaj J. 2021 [80] | Several | 40 (20 + 20) | Cirrhotic outpatients with recurrent HE | FMT 15 capsules vs. SOC Enema (90 mL) vs. SOC |
1 donor rich in Lachnospiraceae and Ruminococcaceae | Less SAEs in antibiotics + FMT Group. |
Beta-lactamase and vancomycin-resistance reduction after FMT, regardless of the mode of administration. No difference in infections. |
Bajaj J. 2019 [78] | Several | 20 | Cirrhotic outpatients with recurrent HE with MELD < 17 | FMT capsules vs. placebo | Not specified | Reduction, at 5 months of number of total HE episodes: 6 vs. 1 and in how many patients (3 vs. 1). | An increase in relative abundance of Lachnospiraceae and Ruminococ caceae. Significant reduction of IL-6. Reduction in total primary BAs and an increase in secondary BAs and secondary/primary BA ratio. No significant changes in MELD. |
Chauhan A. 2020 [84] | HBV | 29 | HBeAg-positive on oral antivirals ≥1 year irrespective of serum levels of HBV-DNA or AST/ALT | In duodenum; 30 g of fresh stool, diluted in 150 mL of saline ×6 cycles at 4 weeks interval | A single healthy donor | Two patients in FMT arm had HBeAg clearance 16.7% vs. 0%. | No achieved HBsAg clearance. DNA became negative faster (25% negative in 6 months). No differences in ALT 6 patients (42.8%) minor adverse events and 1 serious (abdominal pain requiring hospitalization). |
Ren YD, 2017 [83] | HBV | 18 | Persistently positive for HBeAg following >3 years of antiviral; HBV DNA level of <10,000 IU/mL and ALT <80 U/L | FMT to duodenum every 4 weeks until HBeAg clearance was achieved vs. placebo. | Healthy donors. | HBeAg titre declined gradually after each round of FMT; | No HBeAg seroconversion No significant adverse events. |
Abbreviations: PSC: Primary sclerosing cholangitis, UC: Ulcerative colitis, CD: Crohn disease, UDCA: ursodeoxycholic acid, FMT: faecal microbiota transplantation, ALP: alkaline phosphatase, OUT: Operational Taxonomic Unit, AUD: Alcohol use disorders, MELD: Model for End-stage Liver Disease, QOL: quality of life, EtG: ethyl glucuronide, CFU: Colony-forming unit, SCFA: short-chain fatty acids, TIPS: Transjugular intrahepatic portosystemic shunt, IL-6: Interleukin 6, LBP: Lypopolysaccharide binding protein, SOC: standard of care, SAE: serious adverse effects, BA: bile acids, HBV: Hepatitis B virus, HBeAg: hepatitis B virus e-antigen , AST: aspartate amino transferase , ALT: alanine amino transferase.