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Crohn DiseasePhase 2NCT06631586

Standardized Microbiota Transplant Therapy in Crohn's Disease

A Phase 2 study testing MTP-101C and MTP-101S in people with Crohn Disease, run by University of Minnesota at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Crohn Disease
What is being tested?
MTP-101C and MTP-101S
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
15 Jan 2025to 15 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide informed consent.
  • 18-89 years of age.
  • English speaking.
  • Diagnosis of CD based on typical clinical and histologic features.
  • Active disease on endoscopy:
  • SES-CD >= 6
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  • SES-CD >= 4 for isolated ileal disease
  • Current CD therapies are in the maintenance phase of dosing at the time of randomization.
  • Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course.
  • Steroid use 20mg or less by 5 days prior to randomization.
  • Steroid use stipulations:
  • Prednisone must be tapered below 20mg after 7 days.
  • Any use of budesonide over the study period is allowed although tapering is encouraged.
  • Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with the participant and treating provider.
  • Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device).
  • o Periodic abstinence and early withdraw are not acceptable methods.
  • Able to comply with study measures in the opinion of the investigator.

Who cannot join

  • Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.
  • Documented gastroparesis
  • History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.
  • Symptomatic stricture defined as a stricture that:
  • Cannot be traversed by the colonoscope,
  • Requires intervention to be traversed,
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  • Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.
  • Presence of ileostomy or colostomy.
  • Entero-vesicular fistula (i.e., fistula from bowel to bladder).
  • Suspicion of ischemic colitis, radiation colitis or microscopic colitis.
  • Diagnosis of ulcerative colitis.
  • Active or untreated infection.
  • Adenomatous polyps that have not been removed.
  • Use of antibiotics within 14-days of randomization.
  • Current pregnancy.
  • Current breastfeeding or planning to breastfeed over the study period.
  • History of anaphylactic food allergies.
  • End stage liver disease or cirrhosis.
  • Anticipated need for antibiotics over the study period.
  • Anticipated surgical procedure over the study period.
  • An absolute neutrophil count <500 cell/µL.
  • Diagnosis of a primary immunodeficiency.
  • Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).
  • Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.
  • Any solid organ transplant within 6 months of randomization.
  • Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months
  • Life expectancy <=6 months.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Byron Vaughn contact

612-624-0223

bvaughn@umn.edu

United States3 sites, 3 recruiting

  • UT Southwestern

    Dallas, Texas, 75390-9151

    David Fudman, MD, 214-645-6355, David.Fudman@UTSouthwestern.edu

    Diran Tan, BS, 9018717421, Diran.Tan@UTSouthwestern.edu

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Byron Vaughn, bvaughn@umn.edu

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Nathasha Melukkaran, 646-754-3433, Nathasha.Melukkaran@nyulangone.org

    Not yet recruiting

Other trials in United States

About this study

Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.

Conditions
Crohn Disease
Being tested
MTP-101C, MTP-101S
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MTP-101CBiological

    MTP-101C composed of double-encapsulated freeze-dried healthy donor microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and double encapsulated into hypromellose capsules (Lonza, Morristown, NJ). Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

  • MTP-101SBiological

    MTP-101S contains identical healthy donor microbiota double encapsulated in VCaps Plus (Lonza). These capsules are also composed of hypromellose but disintegrate in the proximal small bowel. Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

Study groups in NCT06631586
Study groupRoleWhat they receive
CD patients randomized to MTP-101CExperimentalNot described
Receives: Biological: MTP-101C
CD patients randomized to MTP-101SExperimentalNot described
Receives: Biological: MTP-101S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. donor microbial engraftment

    measured in intestinal ileal biopsies

    Measured: 2months

Secondary outcomes (8)

  1. Changes in ileal microbial composition

    biopsy samples, between baseline and 2 months

    Measured: 2 months

  2. Colonic engraftment of donor microbiota

    colonic biopsies

    Measured: 2 months

  3. Changes in colonic microbial composition

    Measured: 2 months

  4. Engraftment

    measured by fecal samples over the study period.

    Measured: 2 months

  5. Microbial compositional changes

    Measured: 2 months

  6. Changes in clinical symptoms

    measured by the Crohn's Disease Activity Index (CDAI) at baseline, 2-months, and 6-months.

    Measured: baseline, 2 months, 6 months

  7. Endoscopic changes in inflammation

    measured by the Single Endoscopic Score for Crohn's Disease (SES-CD) at baseline and 2-months.

    Measured: 2 months

  8. Safety and tolerability of MTT

    measured by the rate of AEs and SAEs.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start15 Jan 2025
  3. Primary completion15 Jun 2029 (estimated)
  4. Study completion15 Jun 2029 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631586
Sponsor's protocol ID
GI-2024-33127
Status last verified
Sep 2026
First submitted
6 Oct 2024
Last updated
8 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MTP-101C and MTP-101S in people with Crohn Disease, run by University of Minnesota at 3 sites 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 17 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Byron Vaughn (612-624-0223, bvaughn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

donor microbial engraftment (time frame: 2months). 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 NCT06631586.

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 8 Sep 2026.

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