Actively Recruiting
Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-25
214
Participants Needed
11
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Transplantation to Eradicate Colonizing Emergent Superbugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and younger than 105 years
- Positive rectal swab for extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or ESBL-E or CRE infection within the past year
- For ESBL-E carriers, an infection within the past year is required
- Ability to take 50 capsules orally in one day without swallowing problems
- For healthy donors: age 18 to under 50 years
- Healthy donors must have body mass index below 30 kg/m²
- Healthy donors have regular bowel movements (1 stool every 2 days to max 3 stools per day)
You will not qualify if you...
- Current antibiotic treatment except long-term prophylaxis (at least 3 months per year)
- Hospitalization in intensive care unit
- Pregnancy or breastfeeding during the study
- Women of childbearing potential unwilling or unable to use birth control during the study
- Legal protection status
- Participation in another interventional study
- No social security affiliation or under AME
- Refusal to participate in the study
- For healthy donors: history or current proctologic disease or any acute condition risking harm or protocol compliance
- Healthy donors under legal protection
- Healthy donors participating in another interventional study
- Healthy donors without social security or under AME
- Healthy donors refusing participation
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Beaujon Hospital
Clichy, France
Not Yet Recruiting
2
Henri Mondor Hospital
Créteil, France
Not Yet Recruiting
3
Raymond Poincaré Hospital
Garche, France
Not Yet Recruiting
4
Bicêtre Hospital
Le Kremlin-Bicêtre, France
Not Yet Recruiting
5
Bichat Hospital
Paris, France
Not Yet Recruiting
6
Bichat Hospital
Paris, France
Actively Recruiting
7
La Pitié Salpêtrière Hospital
Paris, France
Not Yet Recruiting
8
Lariboisière Hospital
Paris, France
Not Yet Recruiting
9
Saint Antoine Hospital
Paris, France
Not Yet Recruiting
10
Saint Louis Hospital
Paris, France
Not Yet Recruiting
11
Tenon Hospital
Paris, France
Not Yet Recruiting
Research Team
V
Victoire De Lastours, MD, PhD
CONTACT
H
Harry Sokol, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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