Fecal Microbiota Transplant for Ulcerative Colitis

Overseen By Zhi-Dong Jiang, Dr.PH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Antibiotics, Immunosuppressants, Chemotherapy, others

Disqualifiers: Severe UC, Active cancer, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two ways to give healthy gut bacteria to people with active Ulcerative Colitis (UC). One method uses an enema, and the other uses pills. The goal is to see if these treatments are safe and effective by checking changes in gut bacteria and symptoms.

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 cannot participate if you have taken systemic antibiotics within 14 days before the treatment starts or if you are on high doses of certain immune-suppressing drugs like prednisone.

What data supports the effectiveness of this treatment for ulcerative colitis?

Research shows that fecal microbiota transplantation (FMT) can help patients with ulcerative colitis (UC) who haven't responded to other treatments. Studies suggest that FMT can improve symptoms and help maintain long-term remission in UC by introducing beneficial bacteria into the gut. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) safe for humans?

Fecal microbiota transplantation (FMT) is considered safe for treating recurrent Clostridium difficile infections, with established methods for donor screening and processing. However, its safety for other conditions like ulcerative colitis is still being studied, and more data is needed before it can be recommended for routine use in these cases. ^{1 4 6 7 8}

How is fecal microbiota transplantation (FMT) different from other treatments for ulcerative colitis?

FMT is unique because it involves transferring healthy bacteria from a donor's stool to a patient's gut to restore a balanced microbiome, which is different from traditional treatments that often focus on reducing inflammation with drugs. ^{1 2 4 9 10}

Research Team

Herbert L DuPont, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults with active Ulcerative Colitis (UC) who are not pregnant, breastfeeding, or planning pregnancy. They must have a Partial Mayo score ≥ 3 and agree to use birth control. Excluded are those with severe UC, recent antibiotics use, certain infections like HIV/Hepatitis B/C, past FMT or recurrent C. difficile infection within 6 months, compromised immune systems or significant uncontrolled diseases.

Inclusion Criteria

I agree to use effective birth control during the study.

I am not pregnant, as confirmed by a negative pregnancy test.

Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls

Exclusion Criteria

I have a history of active gastrointestinal conditions.

History of use of an investigational drug within 90 days prior to the screening visit

I cannot take medicine as an enema or swallow many pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fecal Microbiota Transplantation (FMT) via retention enema or oral capsules

5 weeks

Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits

Treatment Details

Interventions

• PRIM-DJ2727 - CAPSULES
• PRIM-DJ2727 - FROZEN

Trial Overview The study tests the safety and effectiveness of fecal microbiota transplantation (FMT) in treating UC using two methods: frozen FMT via enema and lyophilized powder in capsules. It also examines changes in gut microbiome diversity after treatment.

Participant Groups

Group I: Experimental: PRIM-DJ2727 - FROZEN Experimental Treatment 1 Intervention

Group II: Experimental: PRIM-DJ2727 - CAPSULES Experimental Treatment 1 Intervention

PRIM-DJ2727 - CAPSULES is already approved in United States, European Union for the following indications:

Approved in United States as Fecal Microbiota Transplantation (FMT) for:

• Recurrent Clostridioides difficile infection

Approved in European Union as Fecal Microbiota Transplantation (FMT) for:

• Recurrent Clostridioides difficile infection

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

In a study of 15 patients with steroid-dependent ulcerative colitis (UC), a step-up fecal microbiota transplantation (FMT) strategy led to clinical improvement in 57.1% of patients, allowing them to discontinue steroid use.

The successful treatment was associated with significant changes in gut microbiota composition, resembling that of the donor, and no severe adverse events were reported, indicating the safety of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. Cui, B., Li, P., Xu, L., et al.[2022]

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]

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]

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]

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]

Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool banks in Denmark.

However, FMT is not recommended for routine use in treating inflammatory bowel disease or irritable bowel syndrome due to insufficient clinical trial data supporting its efficacy for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. Rode, AA., Chehri, M., Petersen, AM., et al.[2019]

High-volume fecal microbiota transplantation (FMT) using an endoscopic jejunal application route effectively cured recurrent Clostridium difficile colitis in all cases studied, demonstrating its efficacy as a treatment option.

While the procedure was generally well tolerated, there is a risk of serious complications, such as aspiration pneumonia, which highlights the need for careful monitoring during FMT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic peroral jejunal fecal microbiota transplantation. Link, A., Lachmund, T., Schulz, C., et al.[2017]

Faecal microbiota transplantation (FMT) is being established as a safe second-line treatment for recurrent Clostridium difficile infections, with a comprehensive framework developed to ensure donor screening and clinical application comply with the European Tissue Act.

The framework includes rigorous donor recruitment and screening processes, laboratory protocols for processing faecal samples, and a structured follow-up system to monitor patient outcomes, ensuring safety and traceability in FMT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation: establishment of a clinical application framework. Jørgensen, SMD., Hansen, MM., Erikstrup, C., et al.[2022]

In a study involving 7 patients with mild to moderate ulcerative colitis, fecal microbiota transplantation (FMT) achieved a donor similarity index (DSI) of 40-50% in about two-thirds of recipients, indicating some level of microbiota engraftment.

Despite achieving this level of engraftment, only one patient experienced a temporary clinical improvement, suggesting that while FMT can alter the microbiota, its efficacy in achieving lasting remission in ulcerative colitis may require further investigation and optimization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. Damman, CJ., Brittnacher, MJ., Westerhoff, M., et al.[2022]

Faecal microbiota transplantation (FMT) has shown effectiveness in inducing remission in active ulcerative colitis (UC), with a clinical remission rate of 28% in FMT patients compared to 9% in placebo groups based on a meta-analysis of randomized controlled trials involving 277 patients.

The study found no major short-term safety concerns associated with FMT, suggesting it is a safe option for patients with UC, although further research is needed to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. Costello, SP., Soo, W., Bryant, RV., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. [2022]

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

Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. [2018]

3. 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]

4. China pubmed.ncbi.nlm.nih.gov

[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Denmark pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Endoscopic peroral jejunal fecal microbiota transplantation. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation: establishment of a clinical application framework. [2022]

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

Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. [2022]

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

Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. [2022]