What is the mechanism of action of this treatment?

The most common treatments for Ulcerative Colitis (UC) include anti-inflammatory drugs, immunosuppressants, and biologics. Anti-inflammatory drugs like mesalamine reduce inflammation in the colon lining. Immunosuppressants such as azathioprine decrease immune system activity to prevent inflammation. Biologics like infliximab target specific proteins involved in the inflammatory process. Fecal Microbiota Transplantation (FMT) aims to restore a healthy gut microbiota by introducing beneficial bacteria from a donor. This is significant for UC patients because an imbalanced gut microbiota is believed to contribute to inflammation and disease symptoms. Restoring a healthy microbiota can potentially reduce inflammation and improve clinical outcomes.

What side effects are associated with this type of intervention?

Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis can cause side effects such as abdominal discomfort, bloating, diarrhea, and, in rare cases, infections. Probiotics, which are also used to modify gut microbiota, may lead to gas, bloating, and, rarely, infections in immunocompromised individuals. Antibiotics like rifaximin, used to treat small intestinal bacterial overgrowth, can cause nausea, abdominal pain, and diarrhea. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including biologics like infliximab and vedolizumab, which target specific components of the immune system to reduce inflammation. While Fecal Microbiota Transplantation (FMT) is being studied for its potential to restore gut microbiota in UC patients, it has not yet received FDA approval for this indication. Current treatments primarily focus on reducing inflammation and modulating the immune response rather than directly altering the gut microbiota.

What other types of research exist?

Promising, novel alternatives to Fecal Microbiota Transplantation for Ulcerative Colitis patients include the use of specific probiotics such as Lactobacillus reuteri, which has shown efficacy in managing gut inflammation. Synbiotics, which combine prebiotics and probiotics, are also being explored for their potential to enhance gut health and reduce UC symptoms. Additionally, targeted antibiotic therapies and dietary modifications, such as exclusive enteral nutrition (EEN), are being investigated for their ability to modulate the gut microbiota and improve clinical outcomes in UC patients.

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Fecal Microbiota Transplantation

Fecal Microbiota Transplant for Ulcerative Colitis

Phase 1

Recruiting

Led By Herbert L DuPont, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after last dose

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from enema administration or taking multiple capsules, digestive disturbances due to changes in gut flora, allergic reactions to donor material, and risk of infection transmission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)

Safety as assessed by the adverse events

Secondary study objectives

Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)

Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental: PRIM-DJ2727 - FROZENExperimental Treatment1 Intervention

Group II: Experimental: PRIM-DJ2727 - CAPSULESExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include anti-inflammatory drugs, immunosuppressants, and biologics. Anti-inflammatory drugs like mesalamine reduce inflammation in the colon lining. Immunosuppressants such as azathioprine decrease immune system activity to prevent inflammation. Biologics like infliximab target specific proteins involved in the inflammatory process. Fecal Microbiota Transplantation (FMT) aims to restore a healthy gut microbiota by introducing beneficial bacteria from a donor. This is significant for UC patients because an imbalanced gut microbiota is believed to contribute to inflammation and disease symptoms. Restoring a healthy microbiota can potentially reduce inflammation and improve clinical outcomes.