Fecal transplantation to Eradicate Colonizing Emergent Superbugs

Fecal transplantation to Eradicate Colonizing Emergent Superbugs - FECES

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004402-10-FR

Enrollment

214

Registered

2020-02-20

Start date

2020-03-11

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients colonized with MDR-GNB (multi-drug resistant Gram Negative bacteria ) MedDRA version: 20.1 Level: LLT Classification code 10028152 Term: Multi-antibiotic resistance System Organ Class: 100000004862

Interventions

Product Name: Fecal microbiota Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Donors: - Healthy subjects =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 71

Exclusion criteria

Exclusion criteria: a) Donors: - Any history of, or current proctologic disease, or any acute condition, which in the investigator’s judgment could harm the volunteer and / or compromise or limit the evaluation of the protocol or data analysis (cf. protocole). - Non-affiliation to a social security scheme (AME excepted) b) Patients: - Antibiotic treatment on the day of inclusion except for long term antibiotic prophylaxis (for at least 3 months/year) - Patients hospitalized in the intensive care unit - Pregnancy or breastfeeding during the study (see definitions in annex 5) - Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study - Patient under legal guardianship - Participation in another trial - Non-affiliation to a social security scheme (AME excepted) NB. If an antibiotic treatment can be anticipated (for ex. prophylaxis treatment for surgery, or expected neutropenia) inclusion should be delayed to limit the use of antibiotics just after FMT.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this two-arm placebo-controlled randomized trial in subjects carrying ESBL-E or CRE in their stool, as determined by culture methods, is to assess whether FMT with frozen capsules from healthy donors is effective for decolonization at 30±10 days post-randomization. ;Secondary Objective: To determine whether FMT with frozen capsules from healthy donors is effective for the: •Decolonization of MDR-GNB carriers at 90±30 days post-randomization •Decolonization of MDR-GNB carriers at 30±10 days and 90± 30 days post-randomization •Prevention of MDR-GNB infections •Reduction of duration of MDR-GNB carriage •Reduction of duration of isolation precautions and hospital stay •Reduction of the relative abundance of resistant strains over the total Enterobacteriaceae •Reduction of antibiotic consumption •To assess the safety and tolerability of FMT •Assess the changes in the microbiota of subjects undergoing FMT •To assess the link between successful decolonization and microbiota profiles prior to FMT and/or microbiota profiles of the donors •To assess factors associated with failure (no decolonization);Primary end point(s): Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 30 (±10 days) after randomization as determined by culture methods. ;Timepoint(s) of evaluation of this end point: day 30	—

Measure

Time frame

Main Objective: The primary objective of this two-arm placebo-controlled randomized trial in subjects carrying ESBL-E or CRE in their stool, as determined by culture methods, is to assess whether FMT with frozen capsules from healthy donors is effective for decolonization at 30±10 days post-randomization. ;Secondary Objective: To determine whether FMT with frozen capsules from healthy donors is effective for the: •Decolonization of MDR-GNB carriers at 90±30 days post-randomization •Decolonization of MDR-GNB carriers at 30±10 days and 90± 30 days post-randomization •Prevention of MDR-GNB infections •Reduction of duration of MDR-GNB carriage •Reduction of duration of isolation precautions and hospital stay •Reduction of the relative abundance of resistant strains over the total Enterobacteriaceae •Reduction of antibiotic consumption •To assess the safety and tolerability of FMT •Assess the changes in the microbiota of subjects undergoing FMT •To assess the link between successful decolonization and microbiota profiles prior to FMT and/or microbiota profiles of the donors •To assess factors associated with failure (no decolonization);Primary end point(s): Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 30 (±10 days) after randomization as determined by culture methods. ;Timepoint(s) of evaluation of this end point: day 30

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Secondary

Measure	Time frame
Secondary end point(s): Prevention of infections: • Occurrence of a clinical infection with ESBL-E or CRE, between inclusion and day 90 • Number of days of use of systemic antibiotics between inclusion and day 90 • Number of days of isolation precautions during the hospital stay • Length of stay in hospital Safety: Occurrence of any adverse event or severe adverse event Microbiology: • Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 90 after randomization • Relative abundance of resistant strains over the total Enterobacteriaceae (expressed as a ratio) • Concentration (expressed in colony-forming units per gram of feces) of resistant strains • Characteristics of ESBL-E/CPE strains (species identification, resistance mechanisms) • 16S microbiome analysis, analysis in terms of diversity and operational taxonomic unit (OTU) presence: o Intra-subject comparison of the microbiome before and after intervention (relative to baseline) o Inter-subjects comparison between donors and patients, donors and receivers, and patients with and without a successful outcome. ;Timepoint(s) of evaluation of this end point: Day 90	—

Measure

Time frame

Secondary end point(s): Prevention of infections: • Occurrence of a clinical infection with ESBL-E or CRE, between inclusion and day 90 • Number of days of use of systemic antibiotics between inclusion and day 90 • Number of days of isolation precautions during the hospital stay • Length of stay in hospital Safety: Occurrence of any adverse event or severe adverse event Microbiology: • Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 90 after randomization • Relative abundance of resistant strains over the total Enterobacteriaceae (expressed as a ratio) • Concentration (expressed in colony-forming units per gram of feces) of resistant strains • Characteristics of ESBL-E/CPE strains (species identification, resistance mechanisms) • 16S microbiome analysis, analysis in terms of diversity and operational taxonomic unit (OTU) presence: o Intra-subject comparison of the microbiome before and after intervention (relative to baseline) o Inter-subjects comparison between donors and patients, donors and receivers, and patients with and without a successful outcome. ;Timepoint(s) of evaluation of this end point: Day 90

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

isabellevivaldo@aphp.fr+330140275724

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026