Clostridium Difficile InfectionPhase 3NCT01958463
Transplantation of Fecal Microbiota for Clostridium Difficile Infection
A Phase 3 study testing Fecal Microbiota transplantation. in people with Clostridium Difficile Infection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal Microbiota transplantation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Dec 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years.
- A negative pregnancy test at inclusion, and a commitment to use contraception for a period of six months from the date of transplant.
- At least one of the following conditions :
- An evidence of Clostridium infection recurrence within 6 months after completion of antibiotic course acceptable, which will include at least 10 days of treatment Bmtronidzol a total dose of 500 mg x3 per day and / or Bonkomitzin dose of at least 125 mg 4x a day .
- Recurrence of infection is defined clinical and laboratory :
- ≥ 3 diarrhea per day for at least two days in a row or ≥ 8 loose stools a day for 48 hours.
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- a positive stool test for Clostridium Difficile toxin, or PCR / antigen detection.
- First infection not responding to antibiotics (at least 10 days Metronidazole dosage of 1500 mg per day , or Bonkomitzin total dose of at least 500 mg per day).
- A first infection in a patient who is intolerant or allergic to Lonkomitzin and metronidazole.
Who cannot join
- Participation in another clinical study.
- Inability to provide informed consent.
- A pregnant woman or breastfeeding.
- Severe neutropenia - below 500 neutrophils (blood counts).
- A significant immunosuppression (SCID, CVID, GVHD, using different preparations Aimonosofrsibiim , including prolonged corticosteroid therapy at doses equivalent to ≥ 20 mg prednisone per day for more than 4 weeks).
- Status of SIRS or hemodynamic/respiratory instability.
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- Toxic Megacolon, ischemic colitis, Fulminant colitis or a higher than usual risk of colon perforatin during colonoscopy.
- HBV infection or hepatitis C or HIV.
- The use of antibiotics for the treatment of another disease at the time of inclusion.
- A history of previous or current autoimmune disease, a progressive/an uncontrolled disease of the kidney/liver/hematological system/endocrine system/ heart/neurological system, or a metabolic disease.
- An addiction to alcohol or drugs.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Gastroenterology Institute
Tel Aviv, Israel, 64239
Noya Horowitz, PhD, 972-3-6974297, noyah@tlvmc.gov.il
About this study
Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection.
The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.
Read the detailed description
Infections by Clostridium Difficile are common both in the community and among hospitalized patients. It is mostly prevalent following an antibiotic treatment. In recent years the investigators are witnessing an increase in severity, incidence and treatment-resistant cases.
Treatment-resistant infection or recurrent infection put the patient at risk for severe complications, such as perforation, septic shock, megacolon and even death.
New antibiotic treatments such as Rifaximin and Fidaxomicin are not yet available for routine use in Israel.
It is known that normal intestinal microbiota protect against Clostridium Difficile infections, and as early as 1958, researchers have demonstrated that a transplantation of fecal microbiota had a beneficial effect on Clostridium Difficile Infection.
In fact, previous data show that microbiota transplantation during colonoscopy, in patients with treatment-resistant infection or recurrent infections, is an effective method with a 90% success rate in a single treatment.
The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile infection.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fecal Microbiota transplantation.
- Keywords
- Clostridium Difficile Infection, Fecal Microbiota Transplantation
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota transplantation.Procedure or surgery
Fecal Microbiota transplantation during colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Fecal microbiota transplantation during colonoscopy. Receives: Procedure: Fecal Microbiota transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Less than 3 bowel movements a day
Measured: 8 weeks after treatment
Secondary outcomes (1)
Negative lab test for Clostridium Difficile
No evidence for Clostridium Difficile in stool test.
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zmir Halpern, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958463
- Sponsor's protocol ID
- TASMC-12-ZH-500-CTIL
- Status last verified
- Oct 2013
- First submitted
- 6 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Fecal Microbiota for Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT01958463
- Acronym / sponsor ID
- TASMC-12-ZH-500-CTIL
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium Difficile Infection, Fecal Microbiota Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- 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.
Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection.
The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.
Detailed description
Infections by Clostridium Difficile are common both in the community and among hospitalized patients. It is mostly prevalent following an antibiotic treatment. In recent years the investigators are witnessing an increase in severity, incidence and treatment-resistant cases.
Treatment-resistant infection or recurrent infection put the patient at risk for severe complications, such as perforation, septic shock, megacolon and even death.
New antibiotic treatments such as Rifaximin and Fidaxomicin are not yet available for routine use in Israel.
It is known that normal intestinal microbiota protect against Clostridium Difficile infections, and as early as 1958, researchers have demonstrated that a transplantation of fecal microbiota had a beneficial effect on Clostridium Difficile Infection.
In fact, previous data show that microbiota transplantation during colonoscopy, in patients with treatment-resistant infection or recurrent infections, is an effective method with a 90% success rate in a single treatment.
The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Procedure: Fecal Microbiota transplantation.Fecal microbiota transplantation during colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age>18 years.
- A negative pregnancy test at inclusion, and a commitment to use contraception for a period of six months from the date of transplant.
- At least one of the following conditions :
Key exclusion criteria (11 listed)
- Participation in another clinical study.
- Inability to provide informed consent.
- A pregnant woman or breastfeeding.
- Severe neutropenia - below 500 neutrophils (blood counts).
- A significant immunosuppression (SCID, CVID, GVHD, using different preparations Aimonosofrsibiim , including prolonged corticosteroid therapy at doses equivalent to ≥ 20 mg prednisone per day for more than 4 weeks).
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 Microbiota transplantation.Fecal Microbiota transplantation during colonoscopy. | Procedure or surgery | Fecal microbiota transplantation |
Primary outcome
Clinical remission
Time frame: 8 weeks after treatment
Less than 3 bowel movements a day
1 secondary outcome
Negative lab test for Clostridium Difficile
Time frame: 8 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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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.
Zmir Halpern, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal Microbiota transplantation. in people with Clostridium Difficile 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 9 inclusion and 11 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 9 Oct 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zamir Halpern, MD (972-36974282, halpernza@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 8 weeks after treatment). 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 9 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.