Ulcerative ColitisPhase 2NCT04434872
Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
A Phase 2 study testing Colonoscopy, Gastroscopy and Fecal Microbiota in people with Ulcerative Colitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Colonoscopy, Gastroscopy and Fecal Microbiota
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Jul 2016
- Phase
- Phase 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 3 month diagnosis of ulcerative colitis
- Active Colitis disease with endoscopic score >0
- Ability to sign an informed consent
Who cannot join
- Acute neutrophilia (under 500 neutrophils)
- Clostridium difficile infection
- Exposure to antibiotics 2 weeks prior to enrollment.
- Severe immune deficiency
- Hospitalization
- Proctitis involving less than 10cm of the rectum
- Malignancy with the past 5 years (excluding BCC)
- An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).
FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.
Read more
Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.
At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.
Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.
- Conditions
- Ulcerative Colitis
- Being tested
- Colonoscopy, Gastroscopy, Fecal Microbiota, Enema
- Keywords
- Microbiota, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Fecal microbiota transplantation through colonoscopy
GastroscopyProcedure or surgery
Fecal microbiota transplantation through gastroscopy
Fecal MicrobiotaDrug
EnemaProcedure or surgery
Fecal microbiota transplantation through enema
| Study group | Role | What they receive |
|---|---|---|
| FMT from a healthy donor | Active comparator | Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. Receives: Procedure: Colonoscopy; Procedure: Gastroscopy; Drug: Fecal Microbiota; Procedure: Enema |
| FMT from a self donated stool sample | Placebo comparator | Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. Receives: Procedure: Colonoscopy; Procedure: Gastroscopy; Drug: Fecal Microbiota; Procedure: Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE
Measured: 8 weeks after FMT
Secondary outcomes (2)
Histological remission assessed by sigmoidoscopy
Will be assessed by sigmoidoscopy
Measured: 8 weeks after FMT
Long term remission assessed through questionnaires
Will be assessed through questionnaires
Measured: one year after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Lack of budget
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434872
- Sponsor's protocol ID
- 0680-14-TLV
- Status last verified
- Jun 2020
- First submitted
- 28 May 2015
- Last updated
- 17 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04434872
- Acronym / sponsor ID
- 0680-14-TLV
- Conditions
- Ulcerative Colitis
- Keywords
- Microbiota, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of budget
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Jun 2020 (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.
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).
FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.
Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.
At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.
Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT from a healthy donor | Active comparator | Procedure: Colonoscopy, Procedure: Gastroscopy, Drug: Fecal Microbiota, Procedure: EnemaPatients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. |
| FMT from a self donated stool sample | Placebo comparator | Procedure: Colonoscopy, Procedure: Gastroscopy, Drug: Fecal Microbiota, Procedure: EnemaPatients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: 1. A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 3 month diagnosis of ulcerative colitis
- Active Colitis disease with endoscopic score >0
- Ability to sign an informed consent
Key exclusion criteria (8 listed)
- Acute neutrophilia (under 500 neutrophils)
- Clostridium difficile infection
- Exposure to antibiotics 2 weeks prior to enrollment.
- Severe immune deficiency
- Hospitalization
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 |
|---|---|---|
| ColonoscopyFecal microbiota transplantation through colonoscopy | Procedure or surgery | FMT from a healthy donor, FMT from a self donated stool sample |
| GastroscopyFecal microbiota transplantation through gastroscopy | Procedure or surgery | FMT from a healthy donor, FMT from a self donated stool sample |
| Fecal Microbiota | Drug | FMT from a healthy donor, FMT from a self donated stool sample |
| EnemaFecal microbiota transplantation through enema | Procedure or surgery | FMT from a healthy donor, FMT from a self donated stool sample |
Primary outcome
Clinical improvement
Time frame: 8 weeks after FMT
A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE
2 secondary outcomes
Histological remission assessed by sigmoidoscopy
Time frame: 8 weeks after FMT
Long term remission assessed through questionnaires
Time frame: one year after FMT
Results and safety
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colonoscopy, Gastroscopy and Fecal Microbiota in people with Ulcerative Colitis, 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 8 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: stopped early, as of the sponsor's last update on 17 Jun 2020. 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 phase mean?
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?
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 8 weeks after FMT). 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 17 Jun 2020.