Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742074
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-02-03
Brief Title:
The Effect of Faecal Microbiota Transplantation FMT on Eradication of Multidrug Resistant Organisms MRO in Intestinal Carriers
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
The Effect of Faecal Microbiota Transplantation FMT on Eradication of Multidrug Resistant Organisms MRO in Intestinal Carriers - a Multicentre Randomized Double-blinded and Placebo-controlled Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEMRO
Brief Summary:
The aim of this study is to investigate the effect of faecal microbiota transplantation FMT on eradication of multidrug resistant organisms MRO in the intestine Ultimately it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO eg Vancomycin resistant Enterococcus Faecium VRE carbapenemase-producing Enterobacterales CPE and extended-spectrum beta-lactamase producing Enterobacterales ESBL-E
Detailed Description:
The study is designed as a randomized double-blinded and placebo-controlled clinical trial The participants n 80 will be randomized 11 to FMT or placebo FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days if one day is unacceptable to the participant At baseline eight weeks and 16 weeks rectal swabs for PCR and culture will be taken Regarding VRE and CPO there are specific PCRs followed by confirmatory culture whereas ESBL-E is detected by culture of rectal swab Furthermore participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None