Minneapolis, MNNCT06370884Now EnrollingIRB Ready

Recurrent Clostridioides Difficile Infection Clinical Trial in Minneapolis, MN

Access cutting-edge recurrent clostridioides difficile infection 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

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related recurrent clostridioides difficile infection treatment provided free

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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 Recurrent Clostridioides Difficile Infection Study in Minneapolis

This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).

Sponsor: University of Minnesota

Who Can Participate

Inclusion Criteria

Able/willing to provide informed consent
Between 18-75 years of age
Undergoing surgery for a history of diverticulitis or sigmoid colon cancer.
Able to provide fecal samples
Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence

Exclusion Criteria

Any history of inflammatory bowel disease
Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential on the proposed day of IMT (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment.
Life expectancy of \< 6 months
Presence of ileostomy or colostomy
Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
Patients with neutropenia (an absolute neutrophil count \< 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening.
History of solid organ or bone marrow transplant.
Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).
History of severe anaphylactic food allergy.
History of celiac disease.
Patients receiving cancer chemotherapy, immunotherapy, or radiation.

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 (NCT06370884) 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.

Recurrent Clostridioides Difficile Infection Treatment Options in Minneapolis, MN

If you're searching for recurrent clostridioides difficile infection treatment options in Minneapolis, MN, this clinical trial (NCT06370884) 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 recurrent clostridioides difficile infection 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 recurrent clostridioides difficile infection clinical trials near you to find additional studies recruiting in your area.

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