Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy

NCT05329636 | Recruiting Phase 1

• 1 other identifier: 0278-18TLV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

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

  A change of \<10% of fecal microbial diversity before antibiotics and after FMT

  4 weeks

Secondary Outcomes (5)

• Side effects rate of auto-FMT delivered through capsules

  4 months

• Side effects rate of auto-FMT delivered through enema

  4 months

• H pylori re-infection rate after auto-FMT procedure

  4 weeks

• Fecal microbial diversity change in auto-FMT delivered through capsules 18 weeks post FMT compared to 4 weeks post FMT

  18 weeks

• Fecal microbial diversity change in auto-FMT delivered through enema 18 weeks post FMT compared to 4 weeks post FMT

  18 weeks

Study Arms (3)

Placebo FMT capsules

PLACEBO COMPARATOR

Glycerol and saline solution will be pipetted into commercially available acid-resistant hypromellose capsules (DRCaps, Capsugel) (650 μL), which will be closed and then secondarily sealed. Capsules will be stored frozen at -80°C (-112°F). Patients will swallow 30 frozen capsules on two consecutive days. Capsules look exactly the same as FMT capsules

Other: Placebo capsules

FMT capsules

EXPERIMENTAL

Fecal matter solution (feces, glycerol and saline solution) will be pipetted into commercially available acid-resistant hypromellose capsules (DRCaps, Capsugel) (650 μL), which will be closed and then secondarily sealed. Capsules will be stored frozen at -80°C (-112°F). Patients will swallow 30 frozen capsules on two consecutive days.

Biological: Fecal Microbial Transplant (FMT)

FMT enemas

ACTIVE COMPARATOR

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/ Fecal matter solution (feces(25 gr of stool , glycerol and saline solution) will be stored at 50 ml tubes frozen at -80°C (-112°F).

Biological: Auto Fecal Microbial Transplant (FMT) via enema

Interventions

Fecal Microbial Transplant (FMT) BIOLOGICAL

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.

FMT capsules

Placebo capsules OTHER

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.

Placebo FMT capsules

Auto Fecal Microbial Transplant (FMT) via enema BIOLOGICAL

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.

FMT enemas

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Nitsan Maharshak, MD

CONTACT

97227360384; nitsanm@tlvmc.gov.il

Rony Izhar, PHD

CONTACT

97237772613; ronyi@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Capsules will be either with FMT or placebo. Same appearance. Patients will be randomized to either arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director, R&D department

Model Details: FMT through capsules FMT through enema- open label in 3-4 patients to examine feasibility Control group without FMT

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: April 15, 2022
• Study Start: September 26, 2018
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)