RecruitingPhase 1Phase 2NCT05329636

Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy

Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection

Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

30 participants

Start Date

Sep 26, 2018

Study Type

INTERVENTIONAL

Conditions

Helicobacter Pylori Infection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria6

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)
Pregnancy
Inability to give informed consent

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Interventions

BIOLOGICALFecal Microbial Transplant (FMT)

FMT 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.

OTHERPlacebo 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 placebo-capsules on two consecutive days.

BIOLOGICALAuto Fecal Microbial Transplant (FMT) via enema

3.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.