What is the mechanism of action of this treatment?

Common treatments for Crohn's Disease often target the gut microbiota to restore a healthy balance of bacteria, which is crucial for reducing inflammation and maintaining remission. Fecal Microbiota Transplant (FMT) involves transferring stool from a healthy donor to the patient's gastrointestinal tract to reintroduce beneficial bacteria. This can help to modulate the immune response, reduce inflammation, and improve gut health. For Crohn's Disease patients, restoring a healthy gut microbiome is essential as it can prevent disease recurrence after surgery and improve overall gastrointestinal function, leading to better disease management and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include anti-tumor necrosis factor agents like infliximab, probiotics, and fecal microbiota transplantation (FMT). Infliximab can cause side effects such as infections, infusion reactions, and potential development of antibodies against the drug. Probiotics are generally safe but may cause mild gastrointestinal symptoms like gas and bloating; however, they should be used cautiously in immunocompromised patients due to a rare risk of systemic infections. FMT, which aims to restore healthy gut bacteria, has shown promise but may lead to transient gastrointestinal symptoms such as diarrhea, abdominal cramping, and bloating. Serious adverse events are rare but can include infections and, in very rare cases, transmission of pathogenic organisms.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Crohn's Disease, including anti-TNF agents like infliximab, adalimumab, and golimumab, which target specific components of the immune system to reduce inflammation. Vedolizumab, a gut-selective integrin antibody, has also been approved for moderate to severe cases. These treatments aim to modulate the immune response and maintain gut health, similar to the goal of fecal microbiota transplantation (FMT), which seeks to restore healthy gut bacteria. While FMT is still under investigation for Crohn's Disease, these biologics represent the current FDA-approved therapies that align with the concept of improving gut microbiome health.

What other types of research exist?

Promising novel alternatives to Fecal Microbiota Transplant (FMT) for Crohn's Disease patients include: 1) Dietary interventions such as the Crohn's Disease Exclusion Diet (CDED) combined with Partial Enteral Nutrition (PEN), which has shown better acceptance and similar remission rates compared to exclusive enteral nutrition. 2) The low FODMAP diet, which may help manage functional gastrointestinal symptoms. 3) Probiotics and synbiotics, which have shown potential in modulating gut microbiota and improving symptoms in some patients. 4) Emerging therapies targeting specific gut bacteria or using bacteriophages to modulate the microbiome. These alternatives offer various approaches to restoring healthy gut bacteria and managing Crohn's Disease.

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FMT for Crohn's Disease

Phase 1

Waitlist Available

Led By Byron Vaughn, MD, MS

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if taking healthy bacteria from donor stool by capsules or colonoscopy can help people with Crohn's disease who have had surgery. The goal is to see if this can prevent the disease from coming back by balancing their gut bacteria.

Who is the study for?

This trial is for adults over 18 with Crohn's Disease who've had ileocecal resection surgery. They must have been diagnosed at least 6 months ago, speak English, and be on stable medications for a month. Women should use birth control or abstain from sex. Participants can't join if they're pregnant, have certain polyps or colectomies, used probiotics or antibiotics recently, expect surgeries during the study, have very low neutrophil counts, severe food allergies, short life expectancy or advanced liver disease.

What is being tested?

The trial tests whether fecal microbiota transplant (FMT) via capsules has similar effects in increasing beneficial gut bacteria as FMT delivered through colonoscopy in post-surgery Crohn's patients. Participants will randomly receive either capsule FMT (cap-FMT) or colonoscopic FMT (colo-FMT), and their gut bacteria will be assessed through biopsies taken during a follow-up colonoscopy after eight weeks.

What are the potential side effects?

Potential side effects of both cap-FMT and colo-FMT may include digestive discomforts such as bloating and cramps; there could also be risks associated with the colonoscopy procedure itself like bleeding or perforation of the bowel wall.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ileal-associated microbiota engraftment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Capsule fecal microbiota material (cap-FMT)Experimental Treatment1 Intervention

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.

Group II: Colonoscopic fecal microbiota material (colo-FMT) plus placeboActive Control1 Intervention

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease often target the gut microbiota to restore a healthy balance of bacteria, which is crucial for reducing inflammation and maintaining remission. Fecal Microbiota Transplant (FMT) involves transferring stool from a healthy donor to the patient's gastrointestinal tract to reintroduce beneficial bacteria. This can help to modulate the immune response, reduce inflammation, and improve gut health. For Crohn's Disease patients, restoring a healthy gut microbiome is essential as it can prevent disease recurrence after surgery and improve overall gastrointestinal function, leading to better disease management and quality of life.