Clinical trial

Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection

Name

0278-18TLV

Description

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.

Trial arms

Trial start

2018-09-26

Estimated PCD

2025-07-01

Trial end

2026-07-01

Status

Recruiting

Phase

Early phase I

Treatment

Fecal Microbial Transplant (FMT)

FMT through capsules- patients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen capsules on two consecutive days.

Arms:

FMT capsules

Placebo capsules

Patients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen placebo-capsules on two consecutive days.

Arms:

Placebo FMT capsules

Auto Fecal Microbial Transplant (FMT) via enema

3.FMT through enema- patients will evacuate the bowel prior to the procedure and will fast for 3 hours prior to the procedure . Patients will receive 80 ml of enema. Enemas will be administered with the assistance of the study nurse. Patients will be asked to hold the enema content for at least 15 minutes.

Arms:

FMT enemas

Size

Primary endpoint

Assessing restoration of the fecal microbiota after 14 day of H. pylori antibiotic regimen

4 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'FMT through capsules FMT through enema- open label in 3-4 patients to examine feasibility Control group without FMT', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Capsules will be either with FMT or placebo. Same appearance. Patients will be randomized to either arm.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-07-08

1 organization

2 products

1 indication

Organization

Tel-Aviv Sourasky Medical Center

Product

Fecal Microbial Transplant

Indication

Helicobacter pylori infection

Product

Auto Fecal Microbial Transplant