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.
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
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