The purpose of this study is to evaluate the efficacy of two antibiotics ( neomycin sulfate and colistin sulfate), followed by fecal bacteria therapy , to multidrug - resistant bacteria (E - ESBL and EPC) to be eradicated from the intestine.
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The purpose of fecal bacteriotherapie is the restoration of the microbial
ecology by a healthy intestinal bacterial flora .
Secondary outcome
Not applicable.
Background summary
The intestinal flora is made up of many different types of bacteria that line
the entire large bowel. These bacteria allow the proper functioning of the body
and are partly eliminated in the stool. A change in diet, an illness,
antibiotics or other drugs may in some people, change the number of bacteria
(decrease or increase) and cause the emergence of antibiotic-resistant bacteria
(called multidrug-resistant bacteria ). Thus, it can happen that those who are
colonized with multi-resistant bacteria, develop an infection with these
bacteria from their own digestive tract and need to be treated with
antibiotics. In this situation, some families of antibiotics may be ineffective.
In the context of a scientific research program, we will conduct a clinical
study consisting of two phases.
* The first phase involves collecting stool containing no multidrug-resistant
bacteria or other infectious agents from voluntary, healthy, qualified donors.
This is the stage in which we invite you to participate.
* The second phase is to administer the processed stool of healthy volunteers
to patients colonized with multidrug-resistant bacteria qualifying as
recipients. The second phase, called fecal bacteriotherapy (FB) is an
innovative medical technology that has demonstrated its ability to eliminate
pathogenic bacteria such as Clostridium difficile from the digestive tract with
great efficacy. FB aims to restore the microbial ecology by reintroducing a
healthy bacterial flora (in this case, yours) via a nasogastric tube. Donor
stools will be used to replace the multidrug-resistant bacteria in the
digestive tract of recipients, specifically extended-spectrum betalactamase
(ESBL-E) or carbapenemase producing Enterobacteriaceae (CPE).
Study objective
The purpose of this study is to evaluate the efficacy of two antibiotics (
neomycin sulfate and colistin sulfate), followed by fecal bacteria therapy , to
multidrug - resistant bacteria (E - ESBL and EPC) to be eradicated from the
intestine.
Study design
A randomized , controlled multicentre trial .
Intervention
* "Control" group : patients assigned to the control group will receive no
special treatment during this study. This is the usual standard for the
treatment of patients colonized with ESBL -E and CRE .
* " Intervention " group : patients will be assigned to the intervention group
asked for 5 days to take two antibiotics ( 4 tablets colistin sulfate and
neomycin sulphate per day ), followed by fecal bacteriotherapie .
Study burden and risks
For donors and patients : The collection of blood can be accompanied by pain
and a hematoma may occur at the site of the puncture. It is possible that
participation in this study reveals that a patient or donor has a dissease if
which he or she is not aware of.
For patients:
* neomycin can cause gastrointestinal symptoms such as nausea, into the rectum.
Vomiting, diarrhea and pain Neurological side effects, such as dizziness,
hearing loss, tinnitus and twitching are rarely seen
* Colistin sulphate may cause intestinal problems, such as nausea , vomiting,
decreased appetite, diarrhea and rare allergic reactions such as skin rash,
hives and itching.
* Omeprazole may cause headaches and gastrointestinal symptoms such as nausea,
vomiting, bloating , abdominal pain , diarrhea or constipation.
* Placing a nasogastric tube can be experienced by the patient as painful. The
insertion can damage the nasal mucosa and cause a nosebleed. An incorrect
positioning of the probe is another rare occurrence risk and can lead to
pneumonia or infections of the mediastinum ( the region of the chest which lies
between the two lungs).
* Fecal bacteriotherapie may cause gastrointestinal symptoms . The duration of
these symptoms is usually limited to a few days ( diarrhea , constipation ,
abdominal pain , abdominal cramps , bloating ) .
* Despite careful selection and examination of the donor stool it is impossible
to conclude with certainty that an unrecognized infectious disease , which is
present at the donor is transferred to you via fecal bacteriotherapie . There
is the possibility for a theoretical risk for the occurrence of autoimmune
diseases or metabolic diseases ( eg . Diabetes) in conjunction with fecal
bacteriotherapie .
* It can not be excluded that there are other risks that hitherto unknown exist.
* Chest X-ray: while taking the X-ray, you will be exposed to a small amount
ionising radiation. There is a small change that the used radiation could lead
to health damage.
Rue Gabrielle-Perret-Gentil 4
Geneva CH-1211
CH
Rue Gabrielle-Perret-Gentil 4
Geneva CH-1211
CH
Listed location countries
Age
Inclusion criteria
For patients:
- Adult patients (18 years at date of inclusion)
- Documented intestinal carriage of ESBL-E and / or CRE by stool culture at baseline (visit 0).
- IF COLONIZED WITH ESBL-E ONLY (WITHOUT CRE): At least one episode of symptomatic infection with ESBL-E requiring systemic antibiotic therapy within the last 180 days before date of inclusion (based on the last day of antibiotic therapy for that infection).;For donors:
- Be aged between 18 and 60 years.
- Be in good health without comorbidities or significant past medical history.
- Have a normal body weight (body mass index between 20 and 25 kg/m2).
- Have a normal macroscopic appearance of stool.
- Have a normal stool frequency (1-3x/day).
Exclusion criteria
For patients:
- Pregnancy or planned pregnancy.
- Breastfeeding.
- Difficult / impossible follow-up.
- Allergy or other contraindication to one of the study drugs.
- Anatomic contraindication to the placement of a nasogastric tube.
- Recurrent aspirations.
- Resistance to colistin (defined as MIC > 2 mg/l) of any of the ESBL-E or CRE strains isolated at baseline.
- Estimated life expectancy < 6 months.
- Treatment with any systemic antibiotic on the day of inclusion.
- Severe immunodeficieny.
* Systemic chemotherapy *30 days from baseline or planned chemotherapy within the next 6 months.
* Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl.
* Prolonged use of steroids (prednisone equivalent * 60 mg per day for > = 30 days) or other immunosuppressive medications.
* neutropenia with absolute neutrophil count < 1000/*L.
* Solid organ transplant recipient.
* Hematopoeitic stem cell transplant recepients.
* Other causes of severe immunodeficiency.
- Hospitalization in an Intensive Care Unit.
- Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2.
- Severe food allergy (anaphylaxis, urticaria).;For donors:
- Not have an acute or chronic digestive disorder.
- Not have a risk behavior for infectious diseases (eg recent change of sexual partner, homosexual intercourse, drug use etc.).
- Not be affected by a chronic disease.
- Not be under long-term treatment.
- Not have had an acute illness or fever in the last 4 weeks.
- Not have stayed in a tropical zone in the last three months or have lived in tropics for many years.
- Not have taken antibiotics in the last 6 months.
- Not have received a tattoo, piercing etc. in the last 6 months.
- Not have undergone a gastroscopy or colonoscopy within the last 6 months.
- Not have received blood products in the past 12 months.
- Not have a history of typhoid fever.
- Not have been hospitalized aborad in the last 12 months.
- Not have stayed in the UK for more than six months between 1980 and 1996.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003727-22-NL |
| ClinicalTrials.gov | NCT02472600 |
| CCMO | NL51282.041.14 |