Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy

NCT ID: NCT05329636

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2026-07-01

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.

Detailed Description

This is a pilot study. Prior to antibiotics therapy for their baseline H.Pylori infection, patients will be asked to deliver at least 50 grams of fresh stool to the Tel Aviv Medical Center (TLVMC) Bacteriotherapy Clinic. All patients will receive therapy to eradicate H. Pylori according to current guidelines (14 days) and physician's discretion, and will be tested to validate H. pylori eradication, at least 21 days post therapy (according to guidelines: Kyoto/ ACG/ Maastricht). For patients that H. pylori was not eradicated- a second line therapy will be administered according to guidelines, and stool will be retrieved at an additional time point, before FMT and after successful H. pylori eradication.

Patients will be allocated into one of three groups:

1. Intervention group- patients will undergo Auto-FMT through capsules.

2. Intervention group-patients will undergo Auto-FMT through enema.

3. Control Group-patients will receive FMT through placebo capsules.

Patients in Intervention group will undergo an additional breath test for H. Pylori, 14-28 days post FMT, to exclude H. pylori-self infection, by the FMT. This concern is related to the capsules therapy, although the fecal filtrate is double packaged in two capsules (one inside another) which are designed to dissolve only in the duodenum at a basic pH.

If patients are found to be re-infected, they will undergo an additional antibiotics course and post eradication will receive FMT through an enema according to the above specified protocol.

FMT capsules will be generated at the laboratory of the Gastrointestinal department at the Tel Aviv Medical Center. The same procedure for FMT generation will be used in this study as in other studies of the IBD unit and in the clinical Bacteriotherapy setting.

FMT administration:

1. FMT through capsules (FMT/placebo)- 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.

2. 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.

At the post-FMT visit and follow -up visits, patients will be examined by a physician who will record clinical symptoms (abdominal pain, nausea, vomiting, weight change), adverse events (fever, abdominal pain, bloating, changes in bowel habits) and general well-being (quality of life and patient reported outcomes questionnaires).

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo FMT capsules

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

Group Type: PLACEBO_COMPARATOR

Placebo capsules

Intervention Type: 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.

FMT capsules

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.

Group Type: EXPERIMENTAL

Fecal Microbial Transplant (FMT)

Intervention Type: 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 enemas

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).

Group Type: ACTIVE_COMPARATOR

Auto Fecal Microbial Transplant (FMT) via enema

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weizmann Institute of Science

OTHER

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shmuel Kivity, MD

director, R&D department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Nitsan Maharshak, MD

Role: CONTACT

nitsanm@tlvmc.gov.il

97227360384

Rony Izhar, PHD

Role: CONTACT

ronyi@tlvmc.gov.il

97237772613

Facility Contacts

Nitsan Maharshak, MD

Role: primary

nitsanm@tlvmc.gov.il

972-3-6947305

Other Identifiers

0278-18TLV

Identifier Type: -

Identifier Source: org_study_id