Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTel-Aviv Sourasky Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Fecal Microbial Transplant (FMT)
  • Placebo capsules
  • Auto Fecal Microbial Transplant (FMT) via enema

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Tel-Aviv Sourasky Medical Center

Lead sponsor

Weizmann Institute of Science

Collaborator