Microbiome Transplantation for Constipation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, PRIM-DJ2727 (a microbiome transplantation therapy), to help individuals with constipation and bloating caused by systemic sclerosis, a condition where the immune system attacks the body's tissues. Researchers aim to determine if this treatment can safely improve gut health and symptoms by using beneficial bacteria. Participants will receive either the new treatment or a placebo to compare results. This trial suits those diagnosed with systemic sclerosis who experience constipation or bloating and are willing to follow study guidelines. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must stop taking probiotic supplements during the study. If you are on immunosuppressive medication, the dose should be stable for at least 4 weeks before joining the trial.
Is there any evidence suggesting that PRIM-DJ2727 is likely to be safe for humans?
Research has shown that PRIM-DJ2727 is generally safe and well-tolerated by patients. In a previous study, participants did not experience serious side effects such as fever or a rapid heartbeat. This indicates that those who received the treatment avoided these specific issues.
The current study is a Phase 2 trial. At this stage, researchers continue to assess safety, but the treatment has already passed initial safety checks in earlier phases. This provides some reassurance about its safety in humans. However, as this is still a Phase 2 trial, the full safety profile is under investigation, and new information may emerge.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for constipation, which typically involve laxatives or fiber supplements, PRIM-DJ2727 is unique because it utilizes microbiome transplantation. This approach aims to restore balance to the gut bacteria, potentially addressing the root cause of constipation rather than just relieving symptoms. Researchers are excited about PRIM-DJ2727 because it represents a novel, holistic way to improve gut health and could offer long-lasting relief for patients.
What evidence suggests that PRIM-DJ2727 might be an effective treatment for constipation?
Research has shown that fecal microbiota transplantation (FMT) can effectively treat constipation by transferring healthy bacteria to balance the gut. Previous studies demonstrated improvements in constipation symptoms following FMT. In the PRIM-DJ2727 trial, participants will receive either the experimental treatment PRIM-DJ2727 or a placebo. The PRIM-DJ2727 treatment aims to increase gut bacteria variety, potentially relieving constipation and bloating in people with systemic sclerosis. This treatment builds on FMT's success in other gut-related conditions.12356
Who Is on the Research Team?
Zsuzsanna McMahan, MD, MHS
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for individuals with Systemic Sclerosis who are experiencing constipation. Participants should have a confirmed diagnosis and be struggling with bowel movements despite trying other treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive microbiome transplantation treatment with PRIM-DJ2727 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PRIM-DJ2727
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor