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Recruiting Phase 1, Phase 2 NCT05329636

Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy

Trial Parameters

Condition Helicobacter Pylori Infection
Sponsor Tel-Aviv Sourasky Medical Center
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2018-09-26
Completion 2025-07-01
Interventions
Fecal Microbial Transplant (FMT)Placebo capsulesAuto Fecal Microbial Transplant (FMT) via enema

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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