NCT04431934: PROFTMDECOL

Efficacy of a Probiotic or Fecal Microbiota Transplantation (FMT) on the Eradication of Rectal Multidrug-resistant Gram-negative Bacilli (MDR-GNB) Carriage (PROFTMDECOL)

Status unknown NA Last updated 12 February 2021

What this trial tests

NA trial testing PROBIOTIC in CARRIER STATE in 437 participants. Status unknown.

Timeline

16 November 2020

Primary endpoint
31 December 2022

1 July 2023

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	437
Start date	16 November 2020
Primary completion	31 December 2022
Estimated completion	1 July 2023
Sites	1 location across Spain

Drugs / interventions tested

• PROBIOTIC
• FMT REGIMEN

Conditions studied

• CARRIER STATE — all drugs for CARRIER STATE →

Sponsor

Hospital Clinic of Barcelona

Who can join

18 and older, any sex, with CARRIER STATE. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The working hypothesis is that in patients who are rectal carriers of MDR-GNB (Multi drug-resistant gram negative bacilli), the rate and speed of eradication of the carrier status obtained with NAA regimens are insufficient and could be improved with additional interventions directed to restore a healthy fecal microbiota or to increase the colonization resistance by the putative beneficial activity of lactate-producing bacteria and bifidobacteria. A healthier colonic microbiota environment is expected not only to promote the eradication of the existing MDR organisms but also to hinder the subsequent recolonization and hopefully the risk of infection with gut dysbiosis -associated pathogens (MDR-GNB, C. difficile and Candida).

The principal objective of the study is To compare the decolonization efficacy at the end of the study (60 ± 7 days after randomization) of the administration of a probiotic ("Vivomixx®" 2 sachets/12h for 2 weeks) versus the administration of two doses (administered a week apart) of a fecal microbiota transplantation preparation (equivalent to 50 g of healthy donor feces) and no treatment (control arm) in patients with rectal colonization with MDRGNB (ESBL-producing Klebsiella pneumoniae, CPE and MDR/XDR (multi drug-resistant/ extensively drug-resistant Pseudomonas aeruginosa).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut Microbiota Modulation and Prevention of Dysbiosis as an Alternative Approach to Antimicrobial Resistance: A Narrative Review.
   Matzaras R, Nikopoulou A, Protonotariou E, Christaki E. · · 2022 · cited 34× · PMID 36568836
2. Faecal microbiota replacement to eradicate antimicrobial resistant bacteria in the intestinal tract - a systematic review.
   Bilsen MP, Lambregts MMC, van Prehn J, Kuijper EJ. · · 2022 · cited 31× · PMID 34636363 · DOI 10.1097/mog.0000000000000792
3. Modulation of the Gut Microbiota to Control Antimicrobial Resistance (AMR)-A Narrative Review with a Focus on Faecal Microbiota Transplantation (FMT).
   Merrick B, Sergaki C, Edwards L, Moyes DL, et al · · 2023 · cited 18× · PMID 37218816 · DOI 10.3390/idr15030025
4. Is there a role of faecal microbiota transplantation in reducing antibiotic resistance burden in gut? A systematic review and Meta-analysis.
   Dharmaratne P, Rahman N, Leung A, Ip M. · · 2021 · cited 17× · PMID 34170204 · DOI 10.1080/07853890.2021.1927170
5. The Role of Fecal Microbiota Transplantation in the Allogeneic Stem Cell Transplant Setting.
   Metafuni E, Di Marino L, Giammarco S, Bellesi S, et al · · 2023 · cited 7× · PMID 37764025 · DOI 10.3390/microorganisms11092182