Table 5.
Characteristics of ongoing clinical trials.
| Trial no./title | Primary outcome | Secondary outcome | Participants/age | Type of study (type/mask) | Country | Status |
|---|---|---|---|---|---|---|
| NCT02472600/Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Faecal Bacteriotherapy (R-GNOSIS WP3) | Intestinal carriage of ESBL-E/CRE 35 to 48 days after randomization | adverse event, Comparison of the global microbiota composition and diversity | 39/adults | Randomized/parallel open label | Switzerland | Active 02/2017 to 03/2018 |
| NCT02922816/FMT for MDRO Colonization After Infection in Renal Transplant Recipients (PREMIX) | The safety and feasibility of using FMT in adult participants with Target MDRO colonization after infection, Change in Target MDRO Growth | Not mentioned | 20/Adults | Randomized/parallel open label | USA | Active 12/2016 to 06/2021 |
| NCT03061097/Autologous Faecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization | Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization. | Number of patients with clearance of ARB among patients colonized at Day 28 | 7/Adults | Randomized/single open label | USA | Active 07/2017 to 06/2019 |
| NCT03063437/A Trial of Encapsulated Faecal Microbiota for Vancomycin Resistant Enterococcus Decolonization | Percentage of Participants With VRE Decolonization | Percentage of Participants With VRE Infection, VRE Decolonization Among Immunocompromised Patients | 9/Adults | Randomized/parallel assignment, quadraple | USA | Completed 06/2020 |
| NCT03643887/Trial of Faecal Microbiota Transplant (FMT) for VRE and CRE Patients | Compare incidence of VRE/CRE decolonization between FMT Capsule | VRE/CRE infection at Day 3, Day 10, and Week 4 following randomization. | 90/Adults | Randomized/double blind | USA | Active 09/2022 to 09/2025 |
| NCT03802461/Effectiveness of Faecal Flora Alteration for Eradication of CPE Colonization | Incidence of CPE colonization in FMT arm vs control arm at 3 months | Incidence of CPE decolonization in FMT-treatment and non-treatment groups at 1, 6 and 12 months, Number of patients with all-cause mortality at 30 days post-randomization | 40/Adults | Randomized/parallel open label | Canada | Recruiting 03/2019 to 12/2020 |
| NCT04146337/Faecal Microbiota Transplantation for CPE | Number of participants achieving CRE eradication at 28 days | Number of participants who died by 28-day and 6-month, Number of participants with CRE bacteraemia and any bacteraemia, Adverse events | 60/Adults | Randomized/parallel open label | Israel | Recruiting 10/2020 to 06/2022 |
| NCT04181112/Faecal Transplant for MDRO Decolonization | The elimination of the target MDR organism | Compare proportions, type and timing of adverse events post-FMT, Proportions and timing of recolonization over 180 days | 90/Adults | Randomized/parallel open label | Canada | Recruiting 11/2019 to 11/2023 |
| NCT04188743/Decolonization of Gram-negative MDRO With Donor Microbiota (FMT) | Number of participants with decolonization success/failure | Side effects, Treatment effect on microbial community | 150/Adults | Randomized/quadraple | Belgium | Recruiting 12/2019 to 12/2023 |
| NCT04431934/Efficacy of a Probiotic or FMT on the Eradication of Rectal MDR Gram-negative Bacilli (MDR-GNB) Carriage (PROFTMDECOL) (PROFTMDECOL) | Proportion of patients with digestive decolonization rate defined as negative rectal swab (RS) for the target MDR-GNB (ESBL-producing K. pneumoniae, CPE and MDR/XDR P. aeruginosa) at the end of study (60 ± 7 days after the randomization) | Any changes with baseline after 1 week, 1 year | 437/Adults | Randomized/parallel open label | Spain | Active/Not recruiting 06/2020 to 07/2023 |
| NCT03061097/Autologous FMT to Prevent AMR Bacteria Colonization (RACE) | Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization | Number of patients with clearance of ARB among patients colonized at Day 28 by PCR assay | 33/Adults | Randomized/parallel multiple | Not mentioned | Completed 12/2020 |
| ACTRN12617000561381/Gastrointestinal eradication of MDR Gram negative bacteria by FMT | Relative abundance of Gram-negative pathogenic organisms in the stool microbial community as assessed by next generation sequencing 1 year of post FMT | Number of episodes of infection, as assessed by positive culture of clinical specimen (not faeces) for resistant Gram-negative organism with same resistance mechanism | Not mentioned/Adults | Randomized/Double blind | Australia | Recruiting not mentioned |
| NCT02592343/A Prospective Trial of Lyophilised Faecal Microbiota Transplantation for Recurrent C. difficile Infection | Efficacy of lyophilised FMT for treatment of recurrent C. difficile infection | Evaluate treatment failure rate as defined by persistence of diarrhoea and a positive C. difficile toxin assay | 100/Adults | Non-randomized/single open label | Canada | Completed 01/2020 |
| NCT03050515/FMT for the treatment of recurrent urinary tract infections | Change in frequency of culture proven urinary tract infections following faecal transplant | Change in the gut microbiome following faecal transplantation measured via 16 s sequencing of stool samples | 12/Adults | Non-randomized/single open label | USA | Completed 02/2020 |
| NCT02543866/FMT as a Strategy to Eradicate Resistant Organisms | Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events | Proportion of subjects free from ESC-R intestinal colonization and recurrent ESC-R infections 2 days, 2 weeks, 4 weeks, 8 weeks, 6 months, and 12 months post-FMT | 20/Adults | Non-randomized/single open label | USA | Recruiting 02/2017 to 02/2024 to |
| NCT02312986/FMT for MDR organism reversal | Safety of FMT in patients with recurrent MDRO infections | Proportion of subjects free from recurrent MDRO infections 30 days, 6 months, and 12 months post-FMT. | 20/adults | Interventional/single open label | USA | Active 05/2015 to 06/2020 |
| NCT02816437/FMT for MDRO Colonization in Solid Organ Transplant (FMT) | Number of participants with adverse events | Rate of MDRO decolonization, rate of recurrent MDRO infection | Not mentioned/Adults | Interventional/single open label | USA | Recruiting 07/2016 to 09/2022 |
| NCT03029078/FMT, a Hope to eradicate colonization of patient harbouring XDR bacteria? | Negative result of the rectal swab performed, free from CRE or GRE | Study with a universal super donor in order to improve efficacy | 50/Adults | Interventional/single open label | France | Active 11/2014 to 01/2024 |
| NCT03167398/FMT for eradication of CRE | 3 consecutive negative rectal samples for CRE after 1 month of trial | Not mentioned | 15/Adults | Interventional/single open label | Israel | Completed 01/2020 |
| NCT03479710/FMT for CRE/VRE | Absence of intestinal colonization of CRE/VRE | Incidence, severity and relatedness of adverse events, changes in intestinal microbiota | 40/Adults | Interventional Parallel open label | Hong Kong | Recruiting 02/2018 to 12/2019 |
| NCT03367910/FMT for MDRO UTI | FMT safety: adverse events during and after FMT | Risk of recurrent UTI post-FMT will be evaluated | 60/Adults | Interventional/single open label | USA | Active 02/2018 to 06/2021 |
| NCT04583098/The Effect of FMT on the decolonization of MDR Organisms | successful decolonization of CPE or VRE in the gut within 3 months | Not mentioned | 100/Adults | Observation/Prospective cohort | Korea | Active 03/2019 to 03/2022 |