Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
ID05329636

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

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

Antibiotic Therapy

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

Post-Antibiotic Testing

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

Auto Fecal Microbial Transplant (FMT) Intervention

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)

Post-FMT Monitoring

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

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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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