Minneapolis, MNNCT06631586Now EnrollingIRB Ready

Crohn Disease Clinical Trial in Minneapolis, MN

Access cutting-edge crohn disease treatment through this clinical trial at a research site in Minneapolis. Study-provided care at no cost to qualified participants.

Sponsored by University of Minnesota

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Expert Care in Minneapolis

Access crohn disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related crohn disease treatment provided free

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Check if you qualify for this crohn disease clinical trial in Minneapolis, MN

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Why Participate?

  • No-Cost Study Care

  • Local to Minneapolis

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Minneapolis site if eligible
  4. 4Begin participation

About This Crohn Disease Study in Minneapolis

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.

Sponsor: University of Minnesota

Who Can Participate

Inclusion Criteria

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
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.

Exclusion Criteria

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,
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Minneapolis?

Yes, this clinical trial (NCT06631586) has an active research site in Minneapolis, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn Disease Treatment Options in Minneapolis, MN

If you're searching for crohn disease treatment options in Minneapolis, MN, this clinical trial (NCT06631586) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Minneapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced crohn disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn disease clinical trials near you to find additional studies recruiting in your area.

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