2026-07-05
minor
Study Status, Outcome Measures v2
Primary completion date2026-05-30→2027-06-30
Completion date2026-09-26→2028-06-30
Secondary endpoints3 to 2 entries
Change in immunoglobulin A (IgA) antibody sequence
2025-06-21
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-06-20→2026-05-30
Completion date2025-09-26→2026-09-26
Start dateestimated 2025-04-02→confirmed 2025-03-03
Eligibility criteria+18 characters
[...] REST criteria for SSc
Meet Rome IV criteria for constipation and/or significant bloating
Subject willing to sign an informed consent form
Subject de [...] the procedure
Subjects who agree to adhere to a stable diet duringfor at least 4 weeks before joining the study and throughout the study
Subjects must have an attending physician who wil [...] r the subject
Exclusion Criteria:
Subjects with constipation and/or significant bloating from causes not attributed to SSc as determined by the trea [...] inflammatory bowel disease, medication, significant diabetes, or hypothyroidism, etc.)
Subjects unwilling to stop taki [...] [...]
Secondary endpoints3 entries, revised
Change in alpha diversity of the microbiome
Change in beta diversity of the microbiome between samples
Primary endpoints5 to 9 entries
Change in symptomsGastrointestinal andSymptom signs of constipationSeverity as assessedAssessed by score on the Patient Assessment of ConstipationGastrointestinal SymptomsDisorders-Symptom Severity Index (PACSYMPAGI-SYM)scale
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (CRADI-8 subscale score)
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20 summary score)
Change in Pelvic Floor Distress as Assessed by the [...]
Change in symptoms and signs of constipation and/or significant bloating a [...] [...]
Study description+712 characters
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 and/or significant b [...]
Study sitesdetails revised at 1 of 1 site
Study title+28 characters
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients withWith Systemic Sclerosis