A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloati… (NCT06827977) | Clinical Trial Compass
RecruitingPhase 2
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
United States21 participantsStarted 2025-03-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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 within weeks 11 to 12
2
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20 summary score)
Timeframe: pre-transplant, post-treatment within weeks 11 to 12
3
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (UDI-6 subscale score)
Timeframe: pre-transplant, post-treatment within weeks 11 to 12
4
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (POPDI-6 subscale score)
Timeframe: pre-transplant, post-treatment within weeks 11 to 12
5
Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (CRADI-8 subscale score)
Timeframe: pre-transplant, post-treatment within weeks 11 to 12
6
Change in symptoms and signs of constipation as assessed by score on the Patient Assessment of Constipation Symptoms (PAC-SYM) scale
Trial details
NCT IDNCT06827977
SponsorThe University of Texas Health Science Center, Houston