Microbiota Transplant Therapy for Crohn's Disease

Overseen By Byron Vaughn

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Must not be taking: Antibiotics

Disqualifiers: Extensive bowel resection, Gastroparesis, Pregnancy, Active infection, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for Crohn's disease using capsules filled with healthy gut bacteria, known as microbiota transplant therapy. Researchers aim to determine if this treatment can balance gut bacteria and reduce inflammation, which causes discomfort in Crohn's disease. The trial will test two types of capsules to identify the more effective option. Individuals with Crohn's disease who experience ongoing symptoms despite treatment and have not recently changed medication may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that any ongoing Crohn's disease therapy, except for steroids, must be at stable doses for 4 weeks before starting the trial and remain stable during the study. Steroid use must be below 20mg by 5 days before starting, and prednisone must be tapered below 20mg after 7 days.

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

Research has shown that fecal microbiota transplantation (FMT) is generally safe for people with Crohn's disease. Studies have found that the MTP-101C treatment can restore gut health without causing serious side effects. Some individuals might experience mild digestive issues, but these typically resolve quickly.

For the MTP-101S treatment, research suggests similar safety. Long-term studies of FMT in general have shown no major problems over several years. Both MTP-101C and MTP-101S use healthy donor bacteria to improve gut health in Crohn's disease patients. This method has also proven successful and safe in treating other conditions, such as recurring C. difficile infections.

In summary, both treatments appear promising, with side effects that are mostly mild and temporary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Microbiota Transplant Therapy for Crohn's Disease because it offers a novel approach by using gut microbiota to restore balance in the digestive system. Unlike standard treatments like immunosuppressants or biologics that primarily target inflammation, this therapy aims to address one of the root causes of the disease by replenishing healthy bacteria in the gut. This could potentially lead to more sustainable remission and fewer side effects. Plus, with treatment arms like MTP-101C and MTP-101S, researchers are exploring specific strains and preparations to optimize results for patients.

What evidence suggests that this trial's treatments could be effective for Crohn's disease?

Research has shown that fecal microbiota transplantation (FMT) could be promising for treating Crohn’s disease. In one analysis, 50.5% of patients experienced significant improvement in their symptoms, known as clinical remission. Another study found that 43.7% of patients responded positively to treatment, and 20.1% maintained long-term symptom relief. Taking FMT in capsule form has also improved both symptoms and internal signs of the disease. In this trial, participants will be randomized to receive either MTP-101C or MTP-101S, both investigational treatments that could help restore gut balance and reduce inflammation in Crohn’s disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Byron Vaughn

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-89 with Crohn's Disease, confirmed by clinical and histologic features. Participants must have a certain level of disease activity (SES-CD ≥ 6, or SES-CD ≥ 4 for isolated ileal disease) and be on stable CD therapies excluding high-dose steroids.

Inclusion Criteria

* Able and willing to provide informed consent.

* English speaking.

* Diagnosis of CD based on typical clinical and histologic features.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive encapsulated FMT material (MTP101C or MTP101S) to assess engraftment in the ileum and colon

8 weeks

Regular visits for monitoring and sample collection

Follow-up

Participants are monitored for safety, tolerability, and changes in clinical symptoms and endoscopic inflammation

4 months

Visits at 2 months and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Standardized Microbiota Transplant Therapy

Trial Overview The study tests two encapsulated fecal microbiota transplant materials, MTP101C and MTP101S, to see if they can settle in the gut of Crohn's patients and improve symptoms. It also looks at how different types of Crohn's affect this process.

How Is the Trial Designed?

Group I: CD patients randomized to MTP-101S Experimental Treatment 1 Intervention

Group II: CD patients randomized to MTP-101C Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) is recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

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]

Fecal microbiota transplantation (FMT) has become a key treatment for Clostridium difficile infection, but its efficacy and safety in patients with underlying inflammatory bowel disease (IBD) are not well established, particularly regarding the risk of IBD flare-ups.

Emerging evidence suggests that FMT may also be beneficial for treating IBD itself, with promising results from randomized trials in ulcerative colitis, although the variability in study outcomes means more research is needed to clarify its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Landscape and Lessons from Fecal Microbiota Transplantation for Inflammatory Bowel Disease: Past, Present, and Future. Allegretti, J., Eysenbach, LM., El-Nachef, N., et al.[2022]

Fecal microbiota transplantation (FMT) shows promise as a potential therapy for Crohn's disease, with some studies indicating higher rates of clinical remission compared to placebo, particularly with multiple FMT treatments.

No serious safety concerns were reported in the studies reviewed, suggesting that FMT is a safe intervention for patients with Crohn's disease, although further large-scale controlled trials are necessary to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation therapy in Crohn's disease: Systematic review. Fehily, SR., Basnayake, C., Wright, EK., et al.[2022]

Fecal microbial transplant (FMT) showed promising results in improving symptoms of Crohn's disease in a study of 9 patients aged 12 to 19, with significant reductions in the Pediatric Crohn's Disease Activity Index (PCDAI) scores from a baseline of 19.7 to 6.4 at 2 weeks.

Most adverse events from FMT were mild and self-limiting, indicating a favorable safety profile, while 7 out of 9 patients demonstrated successful engraftment of the donor microbiome, which correlated with better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease. Suskind, DL., Brittnacher, MJ., Wahbeh, G., et al.[2022]

Fecal microbiota transplantation (FMT) is emerging as a promising strategy to restore normal gut microbiota in patients with inflammatory bowel disease (IBD), potentially complementing existing immune modulation treatments.

While FMT shows potential efficacy, there are still uncertainties regarding the best predictors for treatment response, optimal administration methods, and the ideal characteristics of the transplanted microbiota, highlighting the need for further research on long-term outcomes and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of fecal microbiota transplantation in inflammatory bowel disease. D'Odorico, I., Di Bella, S., Monticelli, J., et al.[2018]

Fecal microbiota transplantation (FMT) has shown promise as an alternative treatment for Crohn's disease, particularly in patients who do not respond to conventional therapies, as demonstrated by a case where a patient achieved clinical remission and endoscopic improvement after a single FMT infusion.

Dysbiosis, or an imbalance in gut microbiota, is linked to chronic inflammation in inflammatory bowel disease (IBD), suggesting that modifying gut microbiota through FMT could help address the underlying causes of Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for refractory Crohn's disease. Bak, SH., Choi, HH., Lee, J., et al.[2022]

In a pilot study involving 15 young participants with mild to moderate Crohn's disease and ulcerative colitis, Fecal Microbiota Transplant (FMT) showed that higher residual microbial diversity after antibiotic treatment was linked to better engraftment and clinical outcomes.

The study identified that a temporary increase in Lactobacillus levels after antibiotics also correlated positively with successful engraftment, suggesting that pre-FMT microbial conditions can significantly influence treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher alpha diversity and Lactobacillus blooms are associated with better engraftment after Fecal Microbiota Transplant in Inflammatory Bowel Disease. Zhang, YJ., Bousvaros, A., Docktor, M., et al.[2023]

Fecal microbial transplantation (FMT) from healthy donors to 19 patients with active Crohn's disease resulted in a significant increase in microbial diversity, which was associated with clinical improvement in 58% of participants.

The study found that FMT was safe, with no serious adverse events reported over 26 weeks, but the variability in clinical response suggests further research is needed to identify factors that influence the effectiveness of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Intestinal Microbial Diversity Following Fecal Microbiota Transplant for Active Crohn's Disease. Vaughn, BP., Vatanen, T., Allegretti, JR., et al.[2023]

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) 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) was found to be safe and effective for treating Crohn's disease, with 66.7% of the 27 patients achieving clinical remission after treatment.

Both gastroscopy and colonoscopy methods of FMT showed similar outcomes in terms of clinical remission rates and mild adverse events, while FMT significantly increased the diversity of gut microbiota in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplant via Endoscopic Delivering Through Small Intestine and Colon: No Difference for Crohn's Disease. Yang, Z., Bu, C., Yuan, W., et al.[2020]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06631586

Standardized Microbiota Transplant Therapy in Crohn's ... 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.

2. withpower.com withpower.com/trial/microbiota-transplant-therapy-for-crohns-disease-e4e02

Microbiota Transplant Therapy for Crohn's Disease This Phase 2 medical study run by University of Minnesota is evaluating whether Standardized Microbiota Transplant Therapy will have tolerable side effects ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6620877/

Fecal microbiota transplant for Crohn disease: A study ... A recent meta-analysis identified 11 studies with 83 patients examining FMT in CD and reported 50.5% achieved clinical remission. However, many of these studies ...

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

Fecal microbiota transplantation restores gut microbiota ... Our study revealed that oral FMT capsules combined with PEN (80%) could help induce clinical remission and achieve endoscopic remission in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7111085/

Efficacy of faecal microbiota transplantation in Crohn's ... By the final follow‐up, 43.7% (76/174) of patients achieved clinical response and 20.1% (35/174) of patients achieved sustained clinical remission based on the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01793831?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(fmt%20crohn's))&rank=4

Standardized Fecal Microbiota Transplantation for Crohn's ... The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI>4). We ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772572323000675

Safety and Efficacy of Fecal Microbiota Transplant in ... In patients with chronic pouchitis, FMT is safe though there are mixed results in terms of its long-term efficacy.