RMT for Colitis

Recruiting at 8 trial locations

Overseen By Ajay Prakash, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Must be taking: Steroids

Disqualifiers: Pregnancy, Infectious colitis, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for colitis (inflammation of the colon) that does not respond to standard steroid treatments. The focus is on oral restorative microbiota therapy (RMT), which involves taking capsules designed to restore healthy gut bacteria. The trial seeks participants who have persistent colitis symptoms despite steroid treatment after using immune checkpoint inhibitors (a type of cancer treatment). Participants must have ongoing diarrhea symptoms even after receiving high-dose steroid treatment and possibly other medications. This research evaluates the safety and feasibility of RMT for those with stubborn colitis linked to cancer therapies. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people, offering participants a chance to benefit from innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not be receiving another investigational agent or have received one within 60 days of enrollment.

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

Research shows that restorative microbiota therapy (RMT), similar to fecal microbiota transplantation (FMT), is generally safe for patients. Studies have found that FMT can restore the balance of gut bacteria and is considered safe. For instance, one study found that 78.9% of patients with inflammatory bowel disease (IBD) who received FMT improved in eight weeks, and 91.1% continued to do well after six months. These results suggest that the treatment is effective and well-tolerated over time.

Another study showed that 50.17% of patients experienced clinical remission, meaning their symptoms improved or disappeared. This indicates that the treatment works for many people without causing serious side effects.

Overall, these findings suggest that RMT is likely safe and manageable for those considering joining a clinical trial for colitis. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for colitis?

Unlike the standard treatments for colitis, which often involve anti-inflammatory drugs or immunosuppressants, restorative microbiota therapy (RMT) works by restoring the balance of gut bacteria through a loading dose of RMT capsules. This innovative approach targets the gut microbiome directly, potentially addressing the root cause of inflammation rather than just alleviating symptoms. Researchers are excited about RMT because it offers a novel mechanism that could lead to longer-lasting remission and fewer side effects compared to traditional therapies.

What evidence suggests that RMT might be an effective treatment for colitis?

Research has shown that fecal microbiota transplantation (FMT) can help treat ulcerative colitis (UC). Studies have found that patients receiving FMT often experience significant improvement compared to those on standard treatments. This method restores a healthy balance of gut bacteria, which is often disrupted in conditions like colitis. For individuals with colitis caused by certain immune system treatments, FMT might offer a new way to manage symptoms when other treatments fail. The positive results from these studies suggest that this therapy could also benefit other gut-related issues. In this trial, participants will receive either Oral restorative microbiota therapy (RMT) or a placebo to evaluate RMT's effectiveness in treating colitis. ^{6 7 8 9 10}

Who Is on the Research Team?

Ajay Prakash, MD, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for patients with severe colitis caused by immune checkpoint inhibitors, who haven't improved after high-dose steroids or other immunosuppressives. They must have adequate organ function and have received at least two doses of ICI therapy within the past six months.

Inclusion Criteria

Patients must meet one of the criteria for steroid refractory IMDC as defined

Patients must be able to provide written consent prior to any research-related activities

My organs are functioning well enough for me to join the study.

Exclusion Criteria

Known current pregnancy or breastfeeding

I have been treated for an infection in my colon.

Receiving or having received another investigational agent within 60 days of study enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral restorative microbiota therapy (RMT) or placebo

30 days

Initial loading dose followed by regular administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits to assess adverse events and clinical remission

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RMT

Trial Overview The study tests oral restorative microbiota therapy (RMT) versus a placebo in managing steroid-refractory immune-mediated diarrhea and colitis (IMDC). It's a pilot randomized controlled trial to evaluate RMT's safety and feasibility.

How Is the Trial Designed?

Group I: RMT group Experimental Treatment 1 Intervention

16 patients will be randomized to Oral restorative microbiota therapy (RMT). Consenting eligible participants receive a loading dose of RMT capsules.

Group II: active placebo Placebo Group 1 Intervention

participants in the placebo arm will receive an identical looking placebo capsules

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 a review of 12 published studies on fecal microbiota transplantation (FMT) for inflammatory bowel disease (IBD), only one study suggested a significant donor effect, while the majority showed no statistically significant differences in efficacy based on donor material.

Despite the lack of strong evidence for donor effects, the study highlights that the existing data cannot completely rule out their potential clinical importance, indicating a need for larger, well-designed trials to explore this further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease. Olesen, SW., Gerardin, Y.[2021]

In a study of 30 patients with ulcerative colitis who did not respond to standard treatments, 70% showed a clinical response to fecal microbial transplantation (FMT) after 12 weeks, with 43.3% achieving both clinical and endoscopic remission.

FMT was found to be a safe alternative to immunosuppressive therapies, with only mild adverse events reported in 23.3% of patients, suggesting it could be a promising option for those with refractory ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. Uygun, A., Ozturk, K., Demirci, H., et al.[2018]

In a double-blind randomized trial involving 50 patients with mild to moderately active ulcerative colitis, fecal microbiota transplantation (FMT) from healthy donors did not show a statistically significant improvement in clinical remission compared to autologous fecal microbiota, with 30.4% of the FMT group achieving remission versus 20.0% in the control group.

Despite the lack of significant differences in remission rates, the microbiota of patients who responded to FMT showed similarities to their healthy donors, suggesting that specific microbial profiles may be associated with treatment response and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Rossen, NG., Fuentes, S., van der Spek, MJ., et al.[2022]

Fecal microbiota transplantation (FMT) showed effectiveness in treating active ulcerative colitis (UC) in a small study of 7 patients, with all participants experiencing improvements in their Mayo scores after the procedure.

While some patients experienced mild and transient side effects like fever and diarrhea, no severe adverse reactions were reported, suggesting that FMT is a relatively safe option for managing active UC, although further research is needed to assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. Ren, R., Sun, G., Yang, Y., et al.[2022]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

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]

This phase Ib pilot study will be the first randomized, single-blinded, placebo-controlled trial assessing the feasibility and outcomes of fecal microbiota transplantation (FMT) in 50 pediatric patients with ulcerative colitis, with treatments administered twice a week for 6 weeks.

The study aims to evaluate the efficacy of FMT by monitoring improvements in disease symptoms using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and analyzing inflammatory markers and microbiome changes, which could lead to novel therapeutic options with fewer side effects for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomised, placebo-controlled pilot study for assessing feasibility and efficacy of faecal microbiota transplantation in a paediatric ulcerative colitis population: PediFETCh trial. Pai, N., Popov, J.[2022]

Citations

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A narrative review on fecal microbiota transplantation routes in ... Fecal microbiota transplantation (FMT) has gained increasing attention as a novel therapeutic approach for treating ulcerative colitis (UC), ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i2364/7971978

P1313 Gut microbiota therapy improves outcomes in ... Patients who received the microbiota-targeted therapy showed significant improvement compared to the standard care group. Disease scores ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11235499/

Efficacy and safety of fecal microbiota transplantation for ... Numerous studies have assessed the efficacy and safety of fecal microbiota transplantation (FMT) as a therapy for ulcerative colitis (UC).

4. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04185-3

The impact of fecal microbiota transplantation on refractory ... Fecal microbiota transplantation (FMT) has shown promise in inducing remission in active ulcerative colitis (UC) by restoring gut microbial ...

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

Microbiota therapeutics for inflammatory bowel disease 35, 36, 55, 56 For induction trials of biologics in ulcerative colitis, clinical remission is expected in 15–30% of actively dosed individuals compared with 5– ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006273/

Fecal microbiota transplantation for patients with ulcerative ... Fecal microbiota transplantation (FMT) has been shown to restore gut microbiome composition with an acceptable safety profile.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05726396

NCT05726396 | A Pilot Study Testing the Safety and ... A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1684118225000647

A pilot study evaluating safety and clinical and microbiota ... In conclusion, FMT appears to be a safe and feasible therapeutic option for IBD patients with refractory or recurrent C. innocuum infection. Further ...

9. academic.oup.com academic.oup.com/ibdjournal/article/31/8/2112/7979239

Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA ... The treatment success rate at 8 weeks was 78.9%, and the sustained clinical response rate at 6 months was 91.1% in participants with IBD, ...

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

Efficacy and safety of fecal microbiota transplantation in the ... Clinical remission was achieved in 146 out of 291 patients (50.17%) in the group that received FMT and 83 out of 286 patients (29.02%) in the ...