Helicobacter Pylori InfectionPhase 1/2NCT05329636
Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy
A Phase 1/2 study testing Fecal Microbial Transplant (FMT) and Auto Fecal Microbial Transplant (FMT) via enema in people with Helicobacter Pylori Infection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Fecal Microbial Transplant (FMT) and Auto Fecal Microbial Transplant (FMT) via enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Sep 2018to 1 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv
Nitsan Maharshak, MD, 972-3-6947305, nitsanm@tlvmc.gov.il
Nitsan Maharshak, MD
About this study
Official title: Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection
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.
Read the 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:
- Intervention group- patients will undergo Auto-FMT through capsules.
- Intervention group-patients will undergo Auto-FMT through enema.
- 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:
- 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.
- 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
- Being tested
- Fecal Microbial Transplant (FMT), Placebo capsules, Auto Fecal Microbial Transplant (FMT) via enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo capsulesOther
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.
Auto Fecal Microbial Transplant (FMT) via enemaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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). Receives: Biological: Auto Fecal Microbial Transplant (FMT) via enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (5)
Side effects rate of auto-FMT delivered through capsules
Side effects will be recorded at every visit and will be compared between the groups
Measured: 4 months
Side effects rate of auto-FMT delivered through enema
Side effects will be recorded at every visit and will be compared between the groups
Measured: 4 months
H pylori re-infection rate after auto-FMT procedure
4 week after each auto-transplantation a breath test for H. Pylori will be performed to evaluate whether auto-FMT results in re-infection. Re-infection is expected to be lower than 10%
Measured: 4 weeks
Fecal microbial diversity change in auto-FMT delivered through capsules 18 weeks post FMT compared to 4 weeks post FMT
The microbial composition and diversity analysis at week 18 will be compared to microbial composition analysis at week 4 in patients receiving FMT through capsules and is expected to be higher than 10% in the intervention group
Measured: 18 weeks
Fecal microbial diversity change in auto-FMT delivered through enema 18 weeks post FMT compared to 4 weeks post FMT
The microbial composition and diversity analysis at week 18 will be compared to microbial composition analysis at week 4 in patients receiving FMT through enema and is expected to be higher than 10% in the intervention group
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start26 Sep 2018
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- FMT through capsules FMT through enema- open label in 3-4 patients to examine feasibility Control group without FMT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Shmuel Kivity, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329636
- Sponsor's protocol ID
- 0278-18TLV
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2020
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT05329636
- Acronym / sponsor ID
- 0278-18TLV
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Intervention group- patients will undergo Auto-FMT through capsules.
- Intervention group-patients will undergo Auto-FMT through enema.
- 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:
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- FMT through capsules FMT through enema- open label in 3-4 patients to examine feasibility Control group without FMT
| Arm | Type | Receives |
|---|---|---|
| Placebo FMT capsules | Placebo comparator | Other: Placebo capsulesGlycerol 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 |
| FMT capsules | Experimental | Biological: Fecal Microbial Transplant (FMT)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. |
| FMT enemas | Active comparator | Biological: Auto Fecal Microbial Transplant (FMT) via enemapatients 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | FMT capsules |
| Placebo capsulesPatients 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. | Other | Placebo FMT capsules |
| Auto Fecal Microbial Transplant (FMT) via enema3.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. | Biological | FMT enemas |
Primary outcome
Assessing restoration of the fecal microbiota after 14 day of H. pylori antibiotic regimen
Time frame: 4 weeks
A change of <10% of fecal microbial diversity before antibiotics and after FMT
5 secondary outcomes
Side effects rate of auto-FMT delivered through capsules
Time frame: 4 months
Side effects rate of auto-FMT delivered through enema
Time frame: 4 months
H pylori re-infection rate after auto-FMT procedure
Time frame: 4 weeks
Fecal microbial diversity change in auto-FMT delivered through capsules 18 weeks post FMT compared to 4 weeks post FMT
Time frame: 18 weeks
Fecal microbial diversity change in auto-FMT delivered through enema 18 weeks post FMT compared to 4 weeks post FMT
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbial Transplant (FMT) and Auto Fecal Microbial Transplant (FMT) via enema in people with Helicobacter Pylori Infection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitsan Maharshak, MD (97227360384, nitsanm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing restoration of the fecal microbiota after 14 day of H. pylori antibiotic regimen (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.