Crohn DiseaseNCT04328922
Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease
A study testing Fecal microbial transplantation in people with Crohn Disease and Microbial Substitution, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial summary
The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's disease (CD) patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease, Microbial Substitution
- What is being tested?
- Fecal microbial transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesIsrael
- Study dates
- 3 Jul 2018to Jan 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
- Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)
Who cannot join
- CD patients in remission (HBI<5) or with sever disease (HBI>16)
- Patients with a stoma
- Hospitalized patients
- Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
- Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
- Pregnant/lactating women
Show all 10Show fewer
- Inability to sign an informed consent
- Inability to complete the study protocol
- An ongoing or planned antibiotics therapy
- Severe food allergies
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Department of Gastroentherology
Tel Aviv, 64239
Nitsan Maharshak, MD, 972-3-6972488, nitsanm@tlvmc.gov.il
Nitsan Maharshak, MD
- 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 Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease
The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's disease (CD) patients.
Primary objective: To determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in higher remission rates in CD patients.
Read more
Study design: A randomized double blinded controlled clinical trial. Study population:CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab.
Study procedure: Study participants will receive FMT within a week prior to first vedolizumab infusion.
All patients will be followed for 46 weeks in 8 visits at the IBD clinic in the GI department of the Tel Aviv Medical Center.
Read the detailed description
Study design: A randomized double blinded controlled clinical trial.
Study population:
CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess) will be enrolled in the study.
Follow-up: All patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup.
Side effects (SE): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. Also, patients will receive direct contact details of both the study coordinator and the study PI.
- Conditions
- Crohn Disease, Microbial Substitution
- Being tested
- Fecal microbial transplantation, Placebo capsuls
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbial transplantationOther
Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
Placebo capsulsOther
capsules of glycerol and saline (placebo).
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbial transplantation | Active comparator | FMT capsules fecal capsules on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion. Patients who will be allocated to this treatment arm will be matched to donors according to their CMV status (past exposure - CMV positive donors will be used for CMV positive patients, and CMV negative donors will be used for CMV negative patients). Receives: Other: Fecal microbial transplantation |
| Placebo | Placebo comparator | Placebo capsules placebo capsules- on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion. Patients who will be allocated to this treatment arm will receive placebo capsules. Receives: Other: Placebo capsuls |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of FMT pre vedolizumab treatment in CD patients
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe.
safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
Measured: week 14
safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe.
safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
Measured: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients.
Remission rate will be measured by clinical remission rate HBI ≤5 at week 14
Measured: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients.
Remission rate will be measured by clinical remission rate HBI ≤5 at week 46
Measured: week 46
Secondary outcomes (10)
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in clinical response rate (reduction in HBI≥3 )
Measured: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
Measured: week 22
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
Measured: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in endoscopic response that will be defined as a decrease of ≥50% in SES-CD score / improvement in Rutgeerts score ≥1, compared to baseline colonoscopy
Measured: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in Endoscopic remission at week 46 will be defined as SES-CD ≤2 or Rutgeerts score ≤1 , compared to baseline colonoscopy
Measured: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in histological healing compared to week 0
Measured: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin<150mg/kg and CRP<5mg/L
Measured: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin<150mg/kg and CRP<5mg/L
Measured: week 22
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin<150mg/kg and CRP<5mg/L
Measured: week 46
safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in lower adverse events rate of intervention versus placebo
Measured: week 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start3 Jul 2018
- Primary completionApr 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double blinded controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328922
- Sponsor's protocol ID
- TASMC-16-NH-0123-CTIL
- Status last verified
- Mar 2020
- First submitted
- 8 Feb 2019
- Last updated
- 1 Apr 2020
- 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 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04328922
- Acronym / sponsor ID
- TASMC-16-NH-0123-CTIL
- Conditions
- Crohn Disease, Microbial Substitution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 1 Apr 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.
The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's disease (CD) patients.
Primary objective: To determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in higher remission rates in CD patients.
Study design: A randomized double blinded controlled clinical trial. Study population:CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab.
Study procedure: Study participants will receive FMT within a week prior to first vedolizumab infusion.
All patients will be followed for 46 weeks in 8 visits at the IBD clinic in the GI department of the Tel Aviv Medical Center.
Detailed description
Study design: A randomized double blinded controlled clinical trial.
Study population:
CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess) will be enrolled in the study.
Follow-up: All patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup.
Side effects (SE): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. Also, patients will receive direct contact details of both the study coordinator and the study PI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized double blinded controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Fecal microbial transplantation | Active comparator | Other: Fecal microbial transplantationFMT capsules fecal capsules on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion. Patients who will be allocated to this treatment arm will be matched to donors according to their CMV status (past exposure - CMV positive donors will be used for CMV positive patients, and CMV negative donors will be used for CMV negative patients). |
| Placebo | Placebo comparator | Other: Placebo capsulsPlacebo capsules placebo capsules- on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion. Patients who will be allocated to this treatment arm will receive placebo capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
- Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)
Key exclusion criteria (10 listed)
- CD patients in remission (HBI<5) or with sever disease (HBI>16)
- Patients with a stoma
- Hospitalized patients
- Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
- Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
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 transplantationCapsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/ | Other | Fecal microbial transplantation |
| Placebo capsulscapsules of glycerol and saline (placebo). | Other | Placebo |
Primary outcome
safety of FMT pre vedolizumab treatment in CD patients
Time frame: week 14
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
Time frame: week 46
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group.
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
Time frame: week 14
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
Time frame: week 46
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 46
10 secondary outcomes
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Time frame: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Time frame: week 22
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
Time frame: week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
Time frame: week 14
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
Time frame: week 22
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
Time frame: week 46
safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
Time frame: week 46
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- 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.
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbial transplantation in people with Crohn Disease and Microbial Substitution, run by Tel-Aviv Sourasky Medical Center at 2 sites 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 2 inclusion and 10 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of FMT pre vedolizumab treatment in CD patients (time frame: week 14). The study lists 4 primary outcomes in all. 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 1 Apr 2020.