💬In plain words
What the trial is, and whether it could suit you
The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion 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 subjects of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period
* Female subjects of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure
* Subjects who agree to adhere to a stable diet for at least 4 weeks before joining the study and throughout the study
* Subjects must have an attending physician who will provide non-transplant care for the subject
Exclusion Criteria:
* Subjects 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.)
* Subjects unwilling to stop taking probiotic supplements during the duration of the study
* Subjects that have post-total or hemicolectomy or the presence of a colostomy
* Subjects unable to tolerate microbiome transplant via enema for any reason or swallow capsules
* Subjects requiring systemic antibiotic therapy 4 weeks before the study
* If subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment