Table 3.
Characteristics of case-series studies (non-duplicate) with and without control arm included for the review.
| Bar-Yoseph et al. [55] | Davido et al. [57] | Huttner et al. [50] | Leo et al. [49] | Saidani et al. [56] | ||
|---|---|---|---|---|---|---|
| Type and place of study | Prospective cohort study, Israel | Pilot prospective monocenter study, France | Multicenter randomized superiority trial, Switzerland, Netherlands, France and Israel | Multicenter randomized clinical trial, Switzerland, Netherlands, France and Israel | A single-center case-control retrospective study | |
| Subjects details | Age range | 21.8–81.3 years | 50–80 years | 23–89 years | 18–64 years | 22–88 years |
| Participants No: | 15 | 08 | 22 | 16 | 10 | |
| Male (M): Female (F) | 10:5 | 5:3 | 10:12 | 8:8 | 8:2 | |
| Indication/colonization status |
K. pneumoniae- KPCa and OXA-48 E. coli- ESBL+b, NDMc, OXA-48, E. cloacae- KPC, E. hormechai- KPC, K. oxytoca- KPC, S. marcescens- KPC C. freundii- KPC |
Cd, Van-A/Van-B |
E. coli – ESBL+, OXA and NDM, K. pneumoniae- ESBL+, E. cloacae- ESBL+, C. freundii- ESBL+, |
ESBL-E and CPE |
K. pneumoniae-OXA-48 and NDM-1, E. coli – OXA-48, E. cloacae-– OXA-48, S. marcescens- OXA-48, A. baumanii- OXA-24, C. freundii- OXA-48, C. koseri- OXA-48 |
|
| Colonization confirmation | Cell cultures and PCRe from 5 samples of rectal swab in the last 6 months | PCR method to determine Van-A/Van-B from the samples taken from a rectal swab | Stool culture | Rectal swab was taken and species identification was done through MOLDI-TOFf resistance patterns via and ABSTsg and RT-PCRsh. | ||
| Pre treatment | Antibiotic | NAi | NA | colistin sulphate and neomycin sulphate tablets for 5 days | Colistin/neomycin | Based upon the type of resistance strain, colistin, and aminoglycosides (amikacin or gentamicin) or sulfadiazine/fusidic acid |
| PPIj | PPI given prior to pre-FMT fasting | PPI given 2 days prior to FMT | Omeprazole 20 mg at the evening of 1 day prior to FMT and the morning of the FMT procedure | NA | Pantoprazole 40 mg twice a day since from 2 days before to FMT | |
| Bowel cleansing | 12 h fasting | Bowel lavage 1 day prior to FMT | NA | NA | First and second bowel wash in 5 days and 1 day before, respectively to the FMT | |
| Donor screening tests |
See Supplementary information, Section 5 | Screened for infectious, metabolic and immune diseases | Done according to the French Agency for the Safety of health Products | According to the 2014 French guidance document for use of FMT in clinical trialsk. | According to the 2014 French guidance document for use of FMT in clinical trials. | NMl |
| FMT | Donor | Unrelated | Unrelated (n = 2) |
Unrelated | Unrelated (n = 7) |
Unrelated |
| Status of intervention sample | frozen faecal capsules | Frozen sample (−80 oC) |
Faecal capsules made up with 80% of glycerol | oral capsules and nasogastric tube | Aseptically prepared sample | |
| Dilution | NA | 1–5 ml of saline per 1 g of faeces | 40 g of stool in 80 ml to prepare the capsules | 40 g of stool in 80 ml of saline | 50 g of stool diluted in 0.9% NaCl 300–400 ml | |
| Dose | 15 capsules/day for 2 days | Five 50 cc syringes | 15 capsules in two consecutive days | 15 capsules in two consecutive days in 2 centres and 80 ml of FMT preparation on a single day in remaining centres | 50g/300 ml in single or double dose | |
| Route | Oral gavage | Nasoduodenal tube | Nasogastric administration | Nasogastric tube | Nasogastric tube or gastrostomy tube | |
| Primary outcome at 1 month time point | CPEm decolonization rate > 50% | VRE decolonization rate was > 50% at one-month time point and it was 87.5% at 3 months. | 40.9% decolonization rate was achieved at 1-month time point | Enterobacteriaceae was lower compared to baseline but without statistical significance | 80% decolonization rate was observed at 1-month time point | |
| Adverse effects | None | None | 90% of the patients in the intervention group have at least 1 adverse event and 4 patients had severe adverse events | None | None | |
| Follow up time | 6 months | 3 months | 7 months | 7 months | 6 months |
aK. pneumoniae carbapenemase; bExtended spectrum β-lactamase; cNew-Delhi metallo-β-lactamase; dVancomycin-resistant Enterococcus; epolymer chain reaction; fMatrix-assisted laser desorption/ionization; gantibiotic sensitivity testing; hReal-time PCRs; iNot applicable; jproton pump inhibitor; khttps://ansm.sante.fr/var/ansm_site/storage/original/application/5e5e01018303790194275ded0e02353c.pdf; lNot mentioned; mcarbapenemase-producing Enterobacteriaceae.