Actively Recruiting
Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection
Led by Tel-Aviv Sourasky Medical Center · Updated on 2024-07-08
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tel-Aviv Sourasky Medical Center
Lead Sponsor
W
Weizmann Institute of Science
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to protect the beneficial gut bacteria in people undergoing antibiotic treatment for Helicobacter pylori infection. This pilot study explores how preserving and then reintroducing a person’s own fecal microbiome could reduce side effects and prevent harm to important bacterial species during the standard 14-day antibiotic regimen used to eliminate H. pylori. The study is conducted in phases 1 and 2 to assess safety and effectiveness of this method. Participants will first provide a fresh stool sample before starting antibiotic treatment. They will then receive standard therapy to eradicate H. pylori for 14 days. After confirming eradication, participants will be randomly assigned to one of three groups: one group will receive their own microbiome transplanted back via capsules, another via enema, and a control group will receive placebo capsules. The fecal microbiome capsules are taken on two consecutive days after bowel preparation, while enemas are administered with nurse assistance and held for at least 15 minutes. During and after treatment, participants will be monitored through clinical visits where symptoms, side effects, and overall well-being will be recorded. Testing will confirm if H. pylori remains eradicated and measure restoration of gut bacterial diversity up to 18 weeks post-transplant. The study also tracks rates of re-infection and side effects over several months to understand the potential benefits and risks of this fecal auto-transplantation approach.
CONDITIONS
Brief Title
Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Severe systemic disease that may impact the microbiome (e.g., 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 for reasons other than H. pylori
- Inability to complete the study protocol (unable to swallow capsules or hold enema content for at least 15 minutes)
- Pregnancy
- Inability to give informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and baseline stool sample collection
Duration - 14 days
Participants receive a 14-day course of antibiotics to eradicate H. pylori infection.
No study visits during antibiotic therapy; treatment as per physician's discretion
Duration - At least 3 weeks after antibiotic therapy
Participants are tested to confirm H. pylori eradication at least 21 days after antibiotic therapy.
1 visit (in-person) for H. pylori testing
Duration - 2 consecutive days
Participants receive auto-FMT via capsules or enema, or placebo capsules, to restore gut microbiota after antibiotic therapy.
1 to 2 visits depending on assigned intervention (capsules or enema)
Duration - Up to 18 weeks post-FMT
Participants are monitored for clinical symptoms, adverse events, and well-being following the FMT procedure.
Multiple visits including a breath test 14-28 days post-FMT and follow-up visits for symptom and safety assessments
Trial Site Locations
Total: 1 location
1
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
Research Team
N
Nitsan Maharshak, MD
R
Rony Izhar, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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