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.
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Change in symptoms and signs of constipation and/or significant bloating as assessed by total score on the University of California, Los Angeles Gastrointestinal Tract Questionnaire, version 2.0 (UCLA GIT 2.0)
Timeframe: pre-transplant , post-treatment at week 12
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20 summary score)
Timeframe: pre-transplant , post-treatment at week 12
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (UDI-6 subscale score)
Timeframe: pre-transplant , post-treatment at week 12
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (POPDI-6 subscale score)
Timeframe: pre-transplant , post-treatment at week 12
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (CRADI-8 subscale score)
Timeframe: pre-transplant , post-treatment at week 12
Change in symptoms and signs of constipation as assessed by score on the Patient Assessment of Constipation Symptoms (PAC-SYM) scale
Timeframe: pre-transplant , post-treatment at week 12
Change in Gastrointestinal Symptom Severity as Assessed by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM)
Timeframe: pre-transplant , post-treatment at week 12
Number of participants who show an improvement in constipation and/or significant bloating symptoms as indicated by the stool diary
Timeframe: from baseline to end of study (week 12)
Change in gut transit times (assessed by Sitz markers and X-ray)
Timeframe: pre-transplant , post-treatment at week 12