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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment FMT for Crohn's Disease?

FMT is considered an alternative treatment with minimal risk for Crohn's disease, as it effectively targets changes in gut bacteria associated with the disease. Additionally, FMT has shown promise in treating other inflammatory bowel diseases like ulcerative colitis and recurrent Clostridioides difficile infections, suggesting its potential effectiveness in Crohn's disease. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) safe for humans?

FMT is generally considered safe for humans, with studies showing minimal risk when used for conditions like Crohn's disease and recurrent Clostridioides difficile infections. Safety measures, such as donor screening and standardized procedures, help ensure its safety. ^{2 3 6 7 8}

How is fecal microbiota transplantation (FMT) unique in treating Crohn's disease?

FMT is unique because it involves transferring healthy bacteria from a donor's stool to a patient's gut, aiming to restore a balanced gut microbiome, which is thought to play a role in Crohn's disease. This approach is different from traditional treatments that often focus on suppressing the immune system or reducing inflammation. ^{1 3 9 10 11}

Research Team

Byron Vaughn, MD, MS

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Protocol for Fecal Microbiota Transplantation in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Colonic and Capsule Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in the treatment of Crohn disease. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Safety of Fecal Microbiota Transplantation for Crohn's Disease: Findings from A Long-Term Study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A comprehensive approach to stool donor screening for faecal microbiota transplantation in China. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. [2021]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Recognition and attitudes of Korean physicians toward fecal microbiota transplantation: a survey study. [2023]