Constipation study: PRIM-DJ2727
Official title A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
ClinicalTrials.gov ID: NCT06827977
What this study is testing
What is PRIM-DJ2727?
This is an investigational treatment being studied for constipation and bloating related to systemic sclerosis. It is designed to introduce specific intestinal bacteria into the gut to help restore a healthy balance of microbes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a gut bacteria transplant can change the bacteria in the gut and improve symptoms of constipation or bloating.
- Who it's for
- You may be able to join if you have systemic sclerosis and have constipation or significant bloating.
- What's involved
- You will receive a transplant of frozen or dried gut bacteria. You will have visits and tests to check your gut bacteria and symptoms.
- Time commitment
- The study lasts about several weeks with a few visits to give the transplant and monitor your symptoms.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are seen in the UT Houston Scleroderma Center (UTHSC)
- Meet 2013 American college of rheumatology (ACR)/European league against rheumatism (EULAR) criteria or CREST criteria for SSc
- Meet Rome IV criteria for constipation and/or significant bloating
- Subject willing to sign an informed consent form
- Subject deemed likely to survive for ≥ 1 year after enrollment
You likely can't join if
- people with constipation and/or significant bloating from causes not attributed to SSc as determined by the treating physician (e.g., inflammatory...
- people unwilling to stop taking probiotic supplements during the duration of the study
- people that have post-total or hemicolectomy or the presence of a colostomy
- people unable to tolerate microbiome transplant via enema for any reason or swallow capsules
- people requiring systemic antibiotic therapy 4 weeks before the study
- If people are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment
See the full eligibility criteria
- Are seen in the UT Houston Scleroderma Center (UTHSC)
- Meet 2013 American college of rheumatology (ACR)/European league against rheumatism (EULAR) criteria or CREST criteria for SSc
- Meet Rome IV criteria for constipation and/or significant bloating
- Subject willing to sign an informed consent form
- Subject deemed likely to survive for ≥ 1 year after enrollment
- Able to follow study procedure and follow-up
- Sexually active male and female people of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- Female people of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure
- people who agree to adhere to a stable diet for at least 4 weeks before joining the study and throughout the study
- people must have an attending physician who will provide non-transplant care for the subject
- people with constipation and/or significant bloating from causes not attributed to SSc as determined by the treating physician (e.g., inflammatory bowel disease, medication, significant diabetes, or hypothyroidism, etc.)
- people unwilling to stop taking probiotic supplements during the duration of the study
- people that have post-total or hemicolectomy or the presence of a colostomy
- people unable to tolerate microbiome transplant via enema for any reason or swallow capsules
- people requiring systemic antibiotic therapy 4 weeks before the study
- If people are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.