Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-105
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years and < 105 years
Healthy subjects ≥ 18 years and < 50 years
Body mass index < 30 kg/m²
Regular bowel movement defined as at least 1 stool every 2 daysand maximum than 3 stools per day
Disqualifiers
Current antibiotic treatment with te exception of long term antibiotic prophylaxis (duration of at least 3 months/year)
Patients hospitalized in the intensive care unit
Pregnancy or breastfeeding during the study
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation (FMT) capsules
Biological/VaccineDonated fecal matter will be sequentially diluted in 80% glycerol used as bacterial cryoprotectant, blenderized, sieved and centrifuged (4°C, 4000 tr/min, 20 min). The pellet is resuspended and manually pipetted into size 0 capsules (650 μL), which are closed and then secondarily sealed in size 00 capsules (hypromellose capsules, DR caps from Capsugel®, MA). Each capsule contains 1g ± 0,1g of fecal suspension corresponding to 0.5 to 0.8g of native stool. Capsules will be stored frozen at -80°C for up to 24 months pending use. The stability of biodiversity and viability of the frozen microbiota was regularly verified to ensure the efficacy of the transplantation (personal data).
Placebo capsules
Biological/VaccineThe "placebo" FMT capsules will be performed with the final dilution solution, ie the 80% glycerol solution used as a cryoprotectant. This solution will be double encapsulated like the FMT capsules.
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: Fecal microbiota Transplant (FMT)Experimental treatment 1 intervention
Group B: Placebo of FMTPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Determine whether FMT with frozen capsules is effective for decolonization of MDR-GNB.
Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 30 (±10 days) after randomization as determined by culture methods
Time frame
30 days post-randomizationSecondary outcomes
1
Prevention of infections
Occurrence of a clinical infection with ESBL-E or CRE, between randomization and day 90
Time frame
90 days post-randomization2
Prevention of infections
Number of days of use of systemic antibiotics between randomization and day 90
Time frame
90 days post-randomization3
Prevention of infections
Number of days of isolation precautions during the hospital stay
Time frame
up to 2 years post-randomization4
Prevention of infections
Length of stay in hospital
Time frame
up to 2 years post-randomizationSponsors and contacts
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Source ClinicalTrials.gov