FMT for Crohn's Disease

Overseen By Sharon Lopez

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Pregnancy, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to prevent Crohn's disease recurrence after surgery using fecal microbiota transplants (FMT). Researchers aim to determine if FMT administered via capsules (cap-FMT) or colonoscopy (colo-FMT) promotes the regrowth of beneficial gut bacteria. Participants will receive either capsules or a colonoscopy treatment, with their gut health assessed 8 weeks later. Individuals who have had Crohn's disease for at least six months and have undergone surgery to remove part of their intestines may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial requires that your medications be stable for 30 days before participating, so you may need to adjust your current medications to meet this requirement. However, the protocol does not specify if you must stop taking them entirely.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using capsules for fecal microbiota transplant (FMT) is generally safe for patients. One study with patients who have ulcerative colitis found that taking FMT capsules by mouth did not lead to any major side effects, indicating they are well-tolerated. Additionally, research has found that FMT can help manage symptoms of Crohn's disease, which is encouraging for those considering this treatment.

For FMT done through a colonoscopy, less information is available, but long-term safety data from a registry in Hong Kong have been positive. Over several years of monitoring, no major safety issues were reported. Overall, both capsule and colonoscopic FMT appear to be safe options for people with Crohn's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Crohn's disease because they involve fecal microbiota transplantation (FMT), a novel approach that targets the gut microbiome directly. Unlike standard treatments that often focus on suppressing the immune system, FMT aims to restore a healthy balance of gut bacteria. The capsule form (cap-FMT) offers a more convenient, non-invasive delivery method compared to traditional colonoscopic administration. This approach has the potential to provide relief more quickly and with fewer side effects, making it an exciting development in Crohn's disease management.

What evidence suggests that FMT might be an effective treatment for Crohn's disease?

Research has shown that fecal microbiota transplantation (FMT) can reduce inflammation in conditions like Crohn's disease. In one study, FMT relieved symptoms in some patients with Crohn's disease. Another study found that taking FMT in capsule form, along with other treatments, showed promise for treating active Crohn's disease in children. While FMT has been effective for similar conditions like ulcerative colitis, less information exists specifically for Crohn's disease. In this trial, participants will receive either capsule fecal microbiota material (cap-FMT) or colonoscopic fecal microbiota material (colo-FMT) plus placebo. Early results suggest that FMT, whether taken as capsules or given through a colonoscopy, could help manage Crohn’s disease after surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Byron Vaughn, MD, MS

Principal Investigator

University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Age 18 or older

English speaking

Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.

Exclusion Criteria

You are pregnant.

Adenomatous polyps that have not been removed

You are expected to take antibiotics during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fecal microbiota transplant (FMT) by capsules or colonoscopy. Colonoscopy is performed at day 0 and week 8, with FMT administered post-colonoscopy.

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular stool swabs and samples collected.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Capsule fecal microbiota material (cap-FMT)
• Colonoscopic fecal microbiota material (colo-FMT)
• FMT

Trial Overview 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.

How Is the Trial Designed?

Group I: Capsule fecal microbiota material (cap-FMT) Experimental Treatment 1 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 placebo Active Control 1 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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In 2018, OpenBiome, a large stool bank, processed 4,271 fecal microbiota transplants (FMT) from 7,536 donations, indicating a robust system for providing FMT material to treat recurrent Clostridioides difficile infections.

The median time from donation to shipment of FMT preparations was 8.9 months, highlighting the need for improved efficiency in the stool banking process to enhance patient access to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. Chen, J., Zaman, A., Ramakrishna, B., et al.[2021]

Fecal microbiota transplantation (FMT) has been successfully used as a rescue therapy for a patient with severe Crohn's disease (CD) complicated by fistula and other complications, marking a significant advancement in treatment options.

This case represents the first reported use of standardized FMT in severe CD, suggesting its potential as a novel therapeutic approach for patients who do not respond to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. Zhang, FM., Wang, HG., Wang, M., et al.[2022]

In a pilot trial involving 17 adults with Crohn's disease, fecal microbiota transplantation (FMT) did not achieve the primary endpoint of successful donor microbiota implantation, but it was associated with a higher rate of steroid-free clinical remission compared to the sham group (87.5% vs 44.4% at 10 weeks).

The study found that while FMT led to a significant decrease in Crohn's Disease Endoscopic Index of Severity, indicating improved disease severity, the absence of donor microbiota engraftment was linked to disease flare-ups, suggesting that successful colonization may be crucial for maintaining remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. Sokol, H., Landman, C., Seksik, P., et al.[2021]

Fecal microbiota transplantation (FMT) has a total adverse event (AE) incidence rate of 28.5%, with abdominal discomfort being the most common AE reported in 19 studies, highlighting the need for careful monitoring during the procedure.

Serious adverse events (SAEs) occurred in 9.2% of patients, with a notable incidence of death (3.5%) and infections (2.5%), indicating that while FMT can be beneficial, it carries significant risks that require further investigation through high-quality randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. Wang, S., Xu, M., Wang, W., et al.[2023]

In a study involving 139 patients with Crohn's disease who underwent fecal microbiota transplantation (FMT), 13.6% experienced mild adverse events within the first month, but no long-term adverse events were reported beyond that period.

The method of fecal microbiota preparation significantly influenced the occurrence of adverse events, with manual preparation leading to a higher rate of 21.7% compared to 8.7% for automatic methods, although this did not affect the overall efficacy of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Fecal Microbiota Transplantation for Crohn's Disease: Findings from A Long-Term Study. Wang, H., Cui, B., Li, Q., et al.[2019]

A study screened 2071 potential stool donors for fecal microbiota transplantation (FMT) in China, resulting in a low selection rate of 3.19%, highlighting the challenges in finding suitable donors.

The research established a donor microbial evaluation index (DoMEI) to improve the screening process, ensuring safety and stability of gut microbiota, which is crucial for the effectiveness of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive approach to stool donor screening for faecal microbiota transplantation in China. He, J., He, X., Ma, Y., et al.[2022]

A survey of 107 Korean physicians revealed that 61.7% had experience with fecal microbiota transplantation (FMT), and 80.4% were willing to use it for treating recurrent Clostridioides difficile infection (CDI).

While two-thirds of physicians would consider FMT for patients with recurrent CDI after three or more recurrences, concerns about regulations and low efficacy for non-CDI diseases were significant barriers to broader use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognition and attitudes of Korean physicians toward fecal microbiota transplantation: a survey study. Gweon, TG., Lee, YJ., Yim, SK., et al.[2023]

Fecal microbiota transplantation (FMT) is a low-risk alternative treatment for patients with Crohn disease, which can help restore healthy gut microbiota.

FMT effectively addresses the changes in gut microbiota that are linked to the development of Crohn disease, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in the treatment of Crohn disease. Collins, M., DeWitt, M.[2021]

The study demonstrated that daily oral administration of frozen encapsulated fecal microbiota transplantation (cFMT) is safe and well-tolerated in patients with mild to moderate ulcerative colitis (UC), with no treatment-related adverse events reported.

Two out of six subjects receiving cFMT achieved clinical remission, suggesting that cFMT may help maintain beneficial changes in gut microbiota and improve clinical outcomes, although further research is needed to confirm these findings and address home storage issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. Crothers, JW., Chu, ND., Nguyen, LTT., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40050917

Fecal microbiota transplantation restores gut ... Conclusions: Oral FMT capsules combined with PEN (80%) could be an effective therapy for children with active CD. The six core functional genera ...

2. journals.lww.com journals.lww.com/ajg/fulltext/2025/06000/preliminary_results_from_a_multicenter,_randomized.24.aspx

Preliminary Results From a Multicenter, Randomized Trial... Clinical remission was achieved in 9/15 patients in the FMT group and 6/11 patients in the placebo group. There were no significant differences in outcomes ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39530534/

Preliminary Results From a Multicenter, Randomized Trial ... This study is the first of its kind to evaluate the efficacy and safety of FMT at inducing remission in Crohn's disease (CD).

4. discoveries.vanderbilthealth.com discoveries.vanderbilthealth.com/2024/03/fecal-transplant-outcomes-in-ulcerative-colitis-crohns/

Fecal Transplant Outcomes in Ulcerative Colitis, Crohn's The most definitive finding was FMT reduced colonic inflammation in UC assessed at a 6-to-12-week follow-up, inducing clinical and endoscopic ...

5. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05832-1

Fecal microbiota transplantation restores gut microbiota ... Data on the use of oral FMT capsules for treating inflammatory bowel disease are limited. Studies have shown that daily oral FMT capsules ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40254304/

Faecal microbiota transplantation in Crohn's disease Yet, there are no placebo controlled trials evaluating the efficacy and safety of faecal microbiota transplantation (FMT) in inducing and ...