What is the mechanism of action of this treatment?

Fecal Microbiota Transplantation (FMT) involves transferring stool from a healthy donor to a UC patient's gastrointestinal tract to restore a balanced gut microbiota, thereby reducing inflammation and improving gut health. This is achieved by increasing microbial diversity and promoting the growth of beneficial bacteria. Other common treatments for UC, such as aminosalicylates, corticosteroids, immunomodulators, and biologics, work by reducing inflammation and modulating the immune response. Understanding these mechanisms is crucial for UC patients to select the most appropriate treatment based on disease severity and individual response.

What side effects are associated with this type of intervention?

Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis is generally considered safe, but potential side effects include gastrointestinal symptoms such as diarrhea, abdominal cramping, and flatulence. There is also a risk of infection transmission and, in rare cases, exacerbation of UC symptoms. Other common treatments for UC, such as mesalamine, can cause side effects like nausea, headache, fever, rash, and, less commonly, pancreatitis and pneumonitis. Corticosteroids, another treatment option, may lead to weight gain, hypertension, diabetes, osteoporosis, and increased infection risk.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including biologic agents like anti-TNF agents (e.g., infliximab, adalimumab), integrin receptor antagonists (e.g., vedolizumab), and Janus kinase inhibitors (e.g., tofacitinib). While Fecal Microbiota Transplantation (FMT) is being studied for its efficacy in UC, it has not yet received FDA approval specifically for this condition. Current research, such as the trial of Lyophilized PRIM-DJ2727 capsules, aims to evaluate the safety and efficacy of FMT in maintaining remission in UC patients.

What other types of research exist?

Promising novel alternatives to Lyophilized PRIM-DJ2727 Capsules (FMT) for Ulcerative Colitis patients include: 1) Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, which has shown efficacy in treating UC. 2) Vedolizumab, an integrin receptor antagonist that inhibits the migration of T-lymphocytes into inflamed gastrointestinal tissue. 3) Risankizumab, another monoclonal antibody targeting interleukin-23, recently approved for Crohn's disease and showing potential for UC. 4) Dietary interventions such as the low-FODMAP diet, which has been shown to improve gastrointestinal symptoms in IBD patients.

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Fecal Microbiota Transplantation

Probiotics for Ulcerative Colitis

Phase 2

Recruiting

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

Adult ≥18 years of age

Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy

Must not have

Females who are pregnant, breastfeeding, or planning to become pregnant during the study

Unable to take multiple capsules orally

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Summary

This trial is testing freeze-dried PRIM-DJ2727 capsules taken by mouth in people with ulcerative colitis who are not currently experiencing symptoms. The treatment might work by changing gut bacteria to help keep the disease from coming back.

Who is the study for?

Adults over 18 with Ulcerative Colitis in remission can join this trial. They must have had active UC within the last year, be on stable therapy, and agree to use birth control if applicable. Exclusions include other GI conditions, certain infections like HIV or Hepatitis B/C, compromised immune systems, recent FMT or investigational drugs, inability to take oral capsules, pregnancy/breastfeeding intentions during the study.

What is being tested?

The trial tests lyophilized PRIM-DJ2727 capsules against placebos for preventing Ulcerative Colitis relapse. It involves taking these orally and monitoring gut microbiota changes over time to see how they relate to clinical outcomes compared with a placebo.

What are the potential side effects?

While specific side effects are not listed here, fecal microbiota transplantation could potentially cause digestive discomforts such as bloating or gas; there's also a risk of infection transmission despite screening donor material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My ulcerative colitis is in remission and I'm on a stable treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I cannot take pills in capsule form.

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I have a history of bile acid diarrhea.

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My immune system is weak due to a condition or medication like high-dose prednisone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Subject-reported score in Hospital Anxiety and Depression Scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Patients with UC will receive FMT capsulesExperimental Treatment1 Intervention

Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors

Group II: Patients with UC will receive placeboPlacebo Group1 Intervention

Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PRIM-DJ2727

2019

Completed Phase 1

~20

0 / 6Eligibility criteria met

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

Fecal Microbiota Transplantation (FMT) involves transferring stool from a healthy donor to a UC patient's gastrointestinal tract to restore a balanced gut microbiota, thereby reducing inflammation and improving gut health. This is achieved by increasing microbial diversity and promoting the growth of beneficial bacteria. Other common treatments for UC, such as aminosalicylates, corticosteroids, immunomodulators, and biologics, work by reducing inflammation and modulating the immune response. Understanding these mechanisms is crucial for UC patients to select the most appropriate treatment based on disease severity and individual response.