A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis

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 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
• * 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