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

The purpose of this study is to evaluate the tolerability and safety of frozen and lyophilized microbiome transplant product (PRIM- DJ2727), to characterize the microbiome (α-diversity and β-diversity) and metabolome in patients with Systemic Sclerosis (SSc)related constipation, to examine improvement in constipation after microbiome transplant by comparing post-treatment with pre- treatment fecal samples and patient-reported outcome measures, to examine improved colonic transit after microbiome transplant , to examine subjective global improvement and improvement in SSc disease characteristics, to monitor change for change in concentration in systemic and fecal inflammatory markers to monitor for change in fecal short-chain fatty acids and metabolome and to provide data that will be used to determine the appropriateness of designing a properly powered clinical trial of microbial restoration treatment in the SSc population