Current guidelines mandate Helicobacter pylori (H. Pylori) eradication with 2-3 antibiotics for 14 days ,This may result in multiple side effects and in eradication of important bacterial species to human health, exposing humans to multiple disease conditions.
Preservation of fecal microbiome prior to antibiotic therapy and auto-transplantation of the microbes post H. pylori eradication, will enable avoiding eradication of beneficial microbial populations and perhaps protect from consequent disease conditions.
Age 18-70 years old
Positive H. pylori on either breath test or gastric biopsy
Patient is intended to receive antibiotics therapy for H. pylori eradication
Severe systemic disease that may impact the microbiome. For example: heart disease, type two diabetes, chronic liver or kidney failure
Antibiotics therapy during the prior 2 months to enrollment
Planned to receive antibiotics within the upcoming 2 months (surgery etc) for reasons other than H. Pylori
Inability to complete the study protocol (swallow capsules or to hold enema content for at least 15 minutes)
Parallel
Fecal Microbial Transplant (FMT)
Biological/VaccineFMT through capsules- patients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen capsules on two consecutive days.
Placebo capsules
Other interventionPatients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen placebo-capsules on two consecutive days.
Auto Fecal Microbial Transplant (FMT) via enema
Biological/Vaccine3.FMT through enema- patients will evacuate the bowel prior to the procedure and will fast for 3 hours prior to the procedure . Patients will receive 80 ml of enema. Enemas will be administered with the assistance of the study nurse. Patients will be asked to hold the enema content for at least 15 minutes.
Assessing restoration of the fecal microbiota after 14 day of H. pylori antibiotic regimen
A change of \<10% of fecal microbial diversity before antibiotics and after FMT
Side effects rate of auto-FMT delivered through capsules
Side effects will be recorded at every visit and will be compared between the groups
Side effects rate of auto-FMT delivered through enema
Side effects will be recorded at every visit and will be compared between the groups
H pylori re-infection rate after auto-FMT procedure
4 week after each auto-transplantation a breath test for H. Pylori will be performed to evaluate whether auto-FMT results in re-infection. Re-infection is expected to be lower than 10%
Fecal microbial diversity change in auto-FMT delivered through capsules 18 weeks post FMT compared to 4 weeks post FMT
The microbial composition and diversity analysis at week 18 will be compared to microbial composition analysis at week 4 in patients receiving FMT through capsules and is expected to be higher than 10% in the intervention group
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Tel-Aviv Sourasky Medical Center
Lead sponsor
Weizmann Institute of Science
Collaborator
