Microbiome Treatment for Colitis

(FMT-ELIMINATE Trial)

Overseen By Amy Rose, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Diwakar Davar

Must be taking: Corticosteroids

Must not be taking: Biologics

Disqualifiers: Immunodeficiency, Immunosuppression, MDRO risk, 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: 3

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MTP-101-C for individuals with colitis, a type of bowel inflammation that hasn't improved with standard treatments like steroids. The study aims to determine if this treatment, derived from healthy bacteria, can reduce inflammation when other options have failed. It specifically targets those with colitis resulting from cancer treatments who have not responded to high-dose steroids. Individuals who have experienced treatment-resistant colitis after cancer therapies and are open to trying a new approach might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have received certain biologic therapies before enrolling, and you should not be on other forms of immunosuppressive therapy besides steroids or biologics within 7 days prior to the trial.

Is there any evidence suggesting that MTP-101-C is likely to be safe for humans?

Earlier studies found that taking fecal microbiota in capsule form is safe for individuals with conditions like irritable bowel syndrome (IBS) and ulcerative colitis. Most participants tolerated the treatment well, and no serious side effects occurred. Another study showed that this treatment could aid people with Crohn's disease without major safety concerns.

The treatment in this trial, called MTP-101-C, also uses fecal microbiota in capsules. This method aligns with those used in previous studies, supporting its safety. Although this trial is in an early stage and requires more detailed safety testing, previous research suggests the treatment is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colitis?

Researchers are excited about MTP-101-C because it harnesses the power of the microbiome to treat colitis, a unique approach compared to traditional therapies. Unlike standard treatments like corticosteroids or biologics, MTP-101-C delivers encapsulated fecal microbiota from healthy donors, introducing beneficial bacteria to the gut. This new method aims to restore balance in the gut microbiome, potentially leading to improved outcomes for patients who are resistant to steroids and have not yet tried biologics. This innovative mechanism could offer a more natural and potentially quicker way to manage colitis symptoms.

What evidence suggests that MTP-101-C might be an effective treatment for colitis?

Research has shown that encapsulated fecal microbiota transplantation (FMT), such as MTP-101-C, can restore gut bacteria balance and help treat certain conditions. Studies have found it effective for repeat Clostridioides difficile infections (rCDI) and inflammatory bowel diseases like ulcerative colitis (UC). A review of research found that encapsulated FMT is as effective and safe as other methods for these conditions. In this trial, participants in different cohorts will receive MTP-101-C to evaluate its effectiveness for colitis and dermatitis in patients unresponsive to steroids or other advanced drugs. Although this treatment is still under study, early results suggest it might benefit these patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Diwakar Davar, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with immune-related skin issues like eczema or colitis that haven't improved after steroid treatment. Participants should have these conditions due to cancer immunotherapy and must not respond well to other biologic treatments.

Inclusion Criteria

Participant provides written informed consent for the trial

Willingness to use contraception for the duration of trial participation

I have previously received immunotherapy targeting PD-1, PD-L1, or CTLA-4.

Exclusion Criteria

Patients at high risk of MDRO colonization

I have experienced multiple immune-related side effects.

I have not received any live vaccines in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive MTP-101-C (encapsulated fecal microbiota) for 28 days, with steroids tapered rapidly

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including endpoint assessments and biospecimen collection

2 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for resolution of symptoms and adverse events up to 2 months

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MTP-101-C

Trial Overview The study tests MTP-101-C, a healthy-donor microbiome therapy, on patients who didn't get better from steroids or biologics for their skin problems or colitis caused by cancer treatments.

How Is the Trial Designed?

Group I: MTP-101-C (Cohort 2: Steroid R/R biologic-naive colitis) Experimental Treatment 1 Intervention

Patients given MTP-101-C (encapsulated fecal microbiota, containing \~5 x 1011 bacteria derived from healthy donors). Dosing: 5 capsules/day (Day 1); 2 capsules/day (D2-D28)

Group II: MTP-101-C (Cohort 1: Steroid R/R biologic-naive dermatitis) Experimental Treatment 1 Intervention

Patients given MTP-101-C (encapsulated fecal microbiota, containing \~5 x 1011 bacteria derived from healthy donors). Dosing: 5 capsules/day (Day 1); 2 capsules/day (D2-D28)

Who Is Running the Clinical Trial?

Diwakar Davar

Lead Sponsor

Trials

12

Recruited

420+

Stanley Marks Fund for Cancer Research

Collaborator

Trials

1

Recruited

30+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

Published Research Related to This Trial

Patients with ulcerative colitis (UC) have a significantly less rich and diverse intestinal microbiota compared to healthy individuals, indicating a potential link between microbiota composition and UC severity.

In patients with active UC, there are notable increases in potentially harmful bacteria and decreases in beneficial butyrate-producing bacteria, suggesting that these microbial changes could serve as biomarkers for disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Composition and diverse differences of intestinal microbiota in ulcerative colitis patients. Zhu, S., Han, M., Liu, S., et al.[2022]

Current standard therapies for inflammatory bowel diseases (IBD) are effective for some patients but often lead to severe side effects and only induce sustained remission in a minority of cases.

Emerging treatments that manipulate the gut microbiota, such as rationally designed oral biotherapeutic products (LBPs) and fecal microbiota transplants, show promise in improving IBD outcomes and may serve as safer alternatives or adjuncts to traditional immunosuppressive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases. Oka, A., Sartor, RB.[2023]

Current treatments for inflammatory bowel disease (IBD) primarily focus on reducing inflammation but many patients do not respond or become resistant, highlighting the need for new therapies.

Fecal microbiota transplant (FMT) shows promise as a potential treatment for IBD by addressing gut microbiota imbalances, but more research is needed to determine the best methods for administration and donor matching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplant - a new frontier in inflammatory bowel disease. Sunkara, T., Rawla, P., Ofosu, A., et al.[2023]

In a case series of 12 patients with severe immune-mediated colitis (IMC) caused by immune checkpoint inhibitors, 83% experienced symptom improvement after fecal microbiota transplantation (FMT), and 92% achieved clinical remission by the end of the study.

Analysis of stool samples indicated that successful FMT responses were linked to specific microbial changes, including increased diversity and the presence of beneficial bacteria like Collinsella and Bifidobacterium, suggesting that gut microbiota composition plays a crucial role in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbiome alteration via fecal microbiota transplantation is effective for refractory immune checkpoint inhibitor-induced colitis. Halsey, TM., Thomas, AS., Hayase, T., et al.[2023]

This case series is the first to show that fecal microbiota transplantation can effectively treat colitis associated with immune checkpoint inhibitors, suggesting a new therapeutic approach.

The treatment led to a reconstitution of the gut microbiome and an increase in regulatory T-cells in the colon, indicating that modifying the gut microbiome may help alleviate inflammation caused by immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for refractory immune checkpoint inhibitor-associated colitis. Wang, Y., Wiesnoski, DH., Helmink, BA., et al.[2022]

In a double-blind trial involving 81 patients with active ulcerative colitis, fecal microbiota transplantation (FMT) significantly increased microbial diversity and altered gut composition, which was linked to remission in patients.

Specific bacteria such as Eubacterium hallii and Roseburia inulivorans were associated with successful remission, while other bacteria like Fusobacterium gonidiaformans were linked to treatment failure, suggesting that understanding these microbial factors could enhance future therapies for ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis. Paramsothy, S., Nielsen, S., Kamm, MA., et al.[2019]

In a study involving 20 patients with recurrent ulcerative colitis, a single fresh fecal microbiota transplant (FMT) led to a significant reduction in disease symptoms compared to a control group, with 90% of FMT patients meeting the primary endpoint at week 8.

The treatment was well-tolerated with no significant adverse events during long-term follow-up, suggesting that FMT could be a safe and effective long-term therapy for inducing remission in active ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of monotherapy with a single fresh fecal microbiota transplant for recurrent active ulcerative colitis: a prospective randomized pilot study. Fang, H., Fu, L., Li, X., et al.[2021]

In a study of 65 IBD patients, those treated with anti-TNF antibodies showed significant changes in their gut microbiome, particularly a decrease in Proteobacteria and an increase in Bacteroidetes, which were linked to clinical remission.

The research also found that patients in remission had a 1.7-fold higher capacity for butyrate production, a beneficial short-chain fatty acid, suggesting that microbial butyrate synthesis could be a key indicator of treatment effectiveness in IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial Butyrate Synthesis Indicates Therapeutic Efficacy of Azathioprine in IBD Patients. Effenberger, M., Reider, S., Waschina, S., et al.[2021]

In a real-world study of 41 steroid-dependent ulcerative colitis patients receiving fecal microbiota transplantation (FMT), 46.3% achieved steroid-free clinical remission after 24 weeks, demonstrating FMT's efficacy in this population.

The treatment was well-tolerated, with no serious adverse events leading to discontinuation, indicating that FMT is a safe option for managing steroid-dependent ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fecal microbiota therapy in steroid dependent ulcerative colitis: a real world intention-to-treat analysis. Sood, A., Mahajan, R., Juyal, G., et al.[2021]

The gut microbiome plays a significant role in inflammatory bowel disease (IBD), but no single microorganism has been identified as the main cause of the disease, indicating a complex interplay of factors.

Fecal microbial transplantation (FMT) shows promise in improving remission rates in ulcerative colitis, although current studies are limited by small sample sizes and varying methods, suggesting a need for more robust research to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gut Microbiome as a Target for IBD Treatment: Are We There Yet? Knox, NC., Forbes, JD., Van Domselaar, G., et al.[2020]

Combining mesalamine with probiotics significantly improves clinical efficacy in treating ulcerative colitis compared to mesalamine alone, with better outcomes observed in both short-term (≤8 weeks) and long-term (>8 weeks) treatments.

The combination treatment does not increase the risk of adverse events, indicating that it is both effective and safe for patients with ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Mesalamine and Probiotics in Mild-to-Moderate Ulcerative Colitis: A Systematic Review and Meta-Analysis. Tian, C., Huang, Y., Wu, X., et al.[2022]

Fecal microbiota transplantation (FMT) was found to be a safe and effective treatment for allergic colitis in infants, with 17 out of 19 infants experiencing symptom relief within 2 days and no relapses over a 15-month follow-up period.

Post-FMT analysis showed significant changes in gut microbiota composition, including increased diversity and a shift in bacterial populations, indicating that FMT not only alleviates symptoms but also helps restore a healthier gut microbiome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation induces remission of infantile allergic colitis through gut microbiota re-establishment. Liu, SX., Li, YH., Dai, WK., et al.[2019]

Research indicates that the gut microbiome plays a crucial role in Crohn's disease and ulcerative colitis, with studies showing reduced microbial diversity and changes in specific bacterial populations associated with disease severity.

Longitudinal studies suggest that monitoring microbial changes can help predict disease activity and treatment response, highlighting the potential for microbiome-based biomarkers in improving patient risk stratification and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbiome-Based Biomarkers for IBD. Ananthakrishnan, AN.[2021]

The study found that patients with microscopic colitis (MC) had a significantly different microbiome composition compared to healthy controls, with lower bacterial diversity before treatment.

Treatment with budesonide improved the microbiome composition in MC patients, increasing diversity and moving it closer to that of healthy individuals, indicating a potential therapeutic effect on gut microbiota.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An altered composition of the microbiome in microscopic colitis is driven towards the composition in healthy controls by treatment with budesonide. Rindom Krogsgaard, L., Kristian Munck, L., Bytzer, P., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34484424/

Systematic review with meta-analysis: encapsulated faecal ... Encapsulated FMT is an effective and safe treatment of rCDI, with cure rates comparable to FMT delivered through other routes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12500633/

Efficacy of encapsulated fecal microbiota transplantation ... The result of this study was similar to the study by El-Salhy et al which highlighted an excellent outcome of FMT in IBS patients by using FMT ...

3. cghjournal.org cghjournal.org/article/S1542-3565(22)00880-1/fulltext

Effectiveness and Safety of Colonic and Capsule Fecal ... There was no difference in the 1-month or 2-month cure rate between cap-FMT and colo-FMT. Cap-FMT recipients were older and less likely to be ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/17562848251369624

Efficacy of different modalities of faecal microbiota ... While several small sample size randomized controlled trials suggested the superiority of faecal microbiota transplantation (FMT) over ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/19490976.2025.2477255

Microbiota transplant therapy in inflammatory bowel disease Clinical outcomes for ulcerative colitis. A Cochrane review published in 2023 evaluated the efficacy of MTT for ulcerative colitis (UC) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314702/

The current landscape of fecal microbiota transplantation in ... This review presents a comprehensive analysis of animal studies and clinical trials exploring using FMT as a treatment for IBD. Understanding ...

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1648944/full

Efficacy of encapsulated fecal microbiota transplantation ... Either encapsulated FMT or FMT via rectal enema was safe and could provide favorable outcomes for IBS patients. Clinical trial registration: ...

8. nature.com nature.com/articles/s41598-023-41182-6

Efficacy and safety of fecal microbiota transplantation in the ... Fecal microbiota transplantation has shown potential as a therapeutic intervention for inducing clinical remission in ulcerative colitis UC.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2468125323004417/pdf

Microbiota therapeutics for inflammatory bowel disease Defined microbiota therapeutics have several advantages over stool-based products, including the increased safety of a fully known composition that markedly ...

10. 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... This study is the first of its kind to evaluate the efficacy and safety of FMT at inducing remission in Crohn's disease (CD).