Irritable Bowel SyndromePhase 1NCT02847481
A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
A Phase 1 study testing fecal microbiota transplantation, FMT with antibiotic pre-treatment (v1) and FMT with antibiotic pre-treatment (v2) in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- fecal microbiota transplantation, FMT with antibiotic pre-treatment (v1) and FMT with antibiotic pre-treatment (v2)
- 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 siteUnited States
- Study dates
- May 2016to 5 Aug 2018
- Phase
- Phase 1
- 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
- IBS with diarrhea
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- fecal microbiota transplantation, placebo fecal microbiota transplantation, FMT with antibiotic pre-treatment (v1), FMT with antibiotic pre-treatment (v2)
- Keywords
- Fecal Microbiota Transplantation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantationProcedure or surgery
fecal microbiota transplantation
placebo fecal microbiota transplantationDrug
placebo fecal microbiota transplantation
FMT with antibiotic pre-treatment (v1)Procedure or surgery
FMT with antibiotic pre-treatment (v1)
FMT with antibiotic pre-treatment (v2)Procedure or surgery
FMT with antibiotic pre-treatment (v2)
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiota transplantation | Experimental | fecal microbiota transplantation Receives: Procedure: fecal microbiota transplantation |
| placebo fecal microbiota transplantation | Placebo comparator | placebo fecal microbiota transplantation Receives: Drug: placebo fecal microbiota transplantation |
| FMT after antibiotic pretreatment v1 | Experimental | fecal microbiota transplantation after antibiotic pretreatment Receives: Procedure: fecal microbiota transplantation; Procedure: FMT with antibiotic pre-treatment (v1) |
| FMT after antibiotic pretreatment v2 | Experimental | fecal microbiota transplantation after antibiotic pretreatment Receives: Procedure: fecal microbiota transplantation; Procedure: FMT with antibiotic pre-treatment (v2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stable engraftment of donor microbiota
Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion5 Aug 2018
- Study completion5 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- OpenBiome
- Responsible party
- Principal investigator, Anthony Lembo, Beth Israel Deaconess Medical Center
- Investigators
- Anthony Lembo, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847481
- Sponsor's protocol ID
- 2015P000211
- Status last verified
- Dec 2019
- First submitted
- 12 Jul 2016
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
PubMed 35014601
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02847481
- Acronym / sponsor ID
- 2015P000211
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Fecal Microbiota Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- OpenBiome
- Study start
- May 2016
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 28 Jul 2016 (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.
This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fecal microbiota transplantation | Experimental | Procedure: fecal microbiota transplantationfecal microbiota transplantation |
| placebo fecal microbiota transplantation | Placebo comparator | Drug: placebo fecal microbiota transplantationplacebo fecal microbiota transplantation |
| FMT after antibiotic pretreatment v1 | Experimental | Procedure: fecal microbiota transplantation, Procedure: FMT with antibiotic pre-treatment (v1)fecal microbiota transplantation after antibiotic pretreatment |
| FMT after antibiotic pretreatment v2 | Experimental | Procedure: fecal microbiota transplantation, Procedure: FMT with antibiotic pre-treatment (v2)fecal microbiota transplantation after antibiotic pretreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS with diarrhea
Key exclusion criteria (0 listed)
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 transplantationfecal microbiota transplantation | Procedure or surgery | FMT after antibiotic pretreatment v1, FMT after antibiotic pretreatment v2, fecal microbiota transplantation |
| placebo fecal microbiota transplantationplacebo fecal microbiota transplantation | Drug | placebo fecal microbiota transplantation |
| FMT with antibiotic pre-treatment (v1)FMT with antibiotic pre-treatment (v1) | Procedure or surgery | FMT after antibiotic pretreatment v1 |
| FMT with antibiotic pre-treatment (v2)FMT with antibiotic pre-treatment (v2) | Procedure or surgery | FMT after antibiotic pretreatment v2 |
Primary outcome
stable engraftment of donor microbiota
Time frame: 10 weeks
Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 35014601Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
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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.
Anthony Lembo, MD principal investigator
Beth Israel Deaconess 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 1 study testing fecal microbiota transplantation, FMT with antibiotic pre-treatment (v1) and FMT with antibiotic pre-treatment (v2) in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 23 Dec 2019. 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 United States. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
stable engraftment of donor microbiota (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847481, which also lists 1 linked publication.
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 23 Dec 2019.