Crohn DiseasePhase 1NCT05248191
FMT for Postop Crohn's Disease
A Phase 1 study testing Capsule fecal microbiota material (cap-FMT) and Colonoscopic fecal microbiota material (colo-FMT) in people with Crohn Disease, run by University of Minnesota at 1 site in United States.
Trial summary
People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Capsule fecal microbiota material (cap-FMT) and Colonoscopic fecal microbiota material (colo-FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 16 May 2024
- 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
- Able and willing to sign informed consent form
- Age 18 or older
- English speaking
- Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
- Prior ileocecal resection for CD
- Stable medications for 30 days
- Women of reproductive age: Agree to remain abstinent or use effective birth control
- Able and willing to comply with all study procedures
Who cannot join
- Antibiotic therapy within 15 days
- Probiotic therapy within 15 days
- Adenomatous polyps that have not been removed
- Anticipated antibiotic use over the study period
- Subtotal or total colectomy
- Current ostomy (ileostomy or colonoscopy)
Show all 12Show fewer
- Anticipated surgical procedure over study period
- Pregnancy
- Severe food allergy
- Diagnosis of end stage liver disease or cirrhosis
- Absolute neutrophil count < 500 cell / uL
- Life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Fecal Microbiota Transplant for Postoperative Crohn's Disease
People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.
This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.
Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.
- Conditions
- Crohn Disease
- Being tested
- Capsule fecal microbiota material (cap-FMT), Colonoscopic fecal microbiota material (colo-FMT)
- Keywords
- Crohn's disease, Ileocecal resection, Fecal microbiota transplant, Intestinal microbiota transplant
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule fecal microbiota material (cap-FMT)Biological
Cap-FMT consists of Lyophilized FMT administered at 5 x 10^11 bacteria per capsule daily for five days, for a total dose of 2.5 x 10^12 bacteria.
Colonoscopic fecal microbiota material (colo-FMT)Biological
Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10^12 bacteria as liquid.
| Study group | Role | What they receive |
|---|---|---|
| Capsule fecal microbiota material (cap-FMT) | Experimental | Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly. Receives: Biological: Capsule fecal microbiota material (cap-FMT) |
| Colonoscopic fecal microbiota material (colo-FMT) plus placebo | Active comparator | Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly. Receives: Biological: Colonoscopic fecal microbiota material (colo-FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ileal-associated microbiota engraftment
Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start20 Apr 2022
- Primary completion25 Dec 2023
- Study completion16 May 2024
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 Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byron Vaughn, MD, MS, Principal investigator, University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248191
- Sponsor's protocol ID
- GI-2022-30546
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moutsoglou D, Staley C, Kabage AJ, Khoruts A, Vaughn BP. Colonoscopic and oral microbiota transplant therapy yield similar stool and neoterminal ileal engraftment profiles in a single-blind pilot randomized trial. Inflamm Bowel Dis. 2026 Aug 1;32(8):1576-1586. doi: 10.1093/ibd/izag096.
PubMed 42334201
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant for Postoperative Crohn's Disease
- ClinicalTrials.gov ID
- NCT05248191
- Acronym / sponsor ID
- GI-2022-30546
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, Ileocecal resection, Fecal microbiota transplant, Intestinal microbiota transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 21 Feb 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.
People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.
This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.
Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Capsule fecal microbiota material (cap-FMT) | Experimental | Biological: Capsule fecal microbiota material (cap-FMT)Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly. |
| Colonoscopic fecal microbiota material (colo-FMT) plus placebo | Active comparator | Biological: Colonoscopic fecal microbiota material (colo-FMT)Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to sign informed consent form
- Age 18 or older
- English speaking
- Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
- Prior ileocecal resection for CD
Key exclusion criteria (12 listed)
- Antibiotic therapy within 15 days
- Probiotic therapy within 15 days
- Adenomatous polyps that have not been removed
- Anticipated antibiotic use over the study period
- Subtotal or total colectomy
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 |
|---|---|---|
| Capsule fecal microbiota material (cap-FMT)Cap-FMT consists of Lyophilized FMT administered at 5 x 10^11 bacteria per capsule daily for five days, for a total dose of 2.5 x 10^12 bacteria. | Biological | Capsule fecal microbiota material (cap-FMT) |
| Colonoscopic fecal microbiota material (colo-FMT)Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10^12 bacteria as liquid. | Biological | Colonoscopic fecal microbiota material (colo-FMT) plus placebo |
Primary outcome
Ileal-associated microbiota engraftment
Time frame: 8 weeks
Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.
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 17 Dec 2025.
- Derived from this study: PubMed 42334201Moutsoglou D, Staley C, Kabage AJ, Khoruts A, Vaughn BP. Colonoscopic and oral microbiota transplant therapy yield similar stool and neoterminal ileal engraftment profiles in a single-blind pilot randomized trial. Inflamm Bowel Dis. 2026 Aug 1;32(8):1576-1586. doi: 10.1093/ibd/izag096.
- 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.
Byron Vaughn, MD, MS principal investigator
University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
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 Capsule fecal microbiota material (cap-FMT) and Colonoscopic fecal microbiota material (colo-FMT) in people with Crohn Disease, run by University of Minnesota 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 8 inclusion and 12 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 17 Dec 2025. 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. 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?
Ileal-associated microbiota engraftment (time frame: 8 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 NCT05248191, 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 17 Dec 2025.