Using fecal microbial transplant after H. pylori antibiotic treatment
Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection
This study is testing if using a stool transplant after antibiotic treatment for H. pylori can help keep beneficial gut bacteria and prevent re-infection.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT05329636 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effects of auto fecal microbial transplant (FMT) following antibiotic therapy for Helicobacter pylori infection. Patients will provide a stool sample before receiving antibiotics, which will be used for FMT after the treatment to preserve beneficial gut bacteria. Participants will be divided into groups receiving FMT via capsules or enema, while a control group will receive placebo capsules. The study will also monitor for H. pylori re-infection post-FMT through breath tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have a confirmed H. pylori infection and are scheduled to undergo antibiotic therapy.
Not a fit: Patients with severe systemic diseases, recent antibiotic use, or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help maintain a healthy gut microbiome and reduce side effects associated with antibiotic treatment for H. pylori.
How similar studies have performed: While the concept of fecal microbial transplant is established, this specific approach post-H. pylori treatment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tel Aviv
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Nitsan Maharshak, MD
- Email: nitsanm@tlvmc.gov.il
- Phone: 97227360384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.