Recruiting
Phase 2

PRIM-DJ2727

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06827977

Conditions

Constipation

Bloating

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRIM-DJ2727

Placebo

Study Details

Brief 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.

Conditions

Constipation

Bloating

Study ID

NCT06827977

Start date

Mar 3, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 4 weeks before the study
  • If subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRIM-DJ2727

placebo comparator: Placebo

Interventions

PRIM-DJ2727

For oral administration, each dose will contain the number of capsules needed to deliver the lyophilized intestinal bacteria powder derived after lyophilization of 60 g of filtered stool in 300 mL 0.85% NaCl and 2% mannitol. Participants will take the capsules (5-6 capsules twice weekly) from week 2 through week 10. Capsules will be taken over a period of up to one hour to maximize tolerance and ensure the capsules are not expelled by vomiting.

For administration via retention enema, which will be done at baseline and week 11, 50 g of filtered, frozen stool in 250 mL of 0.85% sodium chloride (NaCl) will be used.

Placebo

Placebo will be administered as capsules from week 2-10 and as enema at baseline and week 11.

Primary outcome measure

  • 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) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20 summary score) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (UDI-6 subscale score) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (POPDI-6 subscale score) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Change in Pelvic Floor Distress as Assessed by the Pelvic Floor Distress Inventory Questionnaire-20 (CRADI-8 subscale score) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Change in symptoms and signs of constipation as assessed by score on the Patient Assessment of Constipation Symptoms (PAC-SYM) scale [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Change in Gastrointestinal Symptom Severity as Assessed by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]
  • Number of participants who show an improvement in constipation and/or significant bloating symptoms as indicated by the stool diary [ Time Frame: from baseline to end of study (week 12) ]
  • Change in gut transit times (assessed by Sitz markers and X-ray) [ Time Frame: pre-transplant, post-treatment within weeks 11 to 12 ]

Central Contacts and Locations

Central contacts

Zsuzsanna McMahan, MD, MHS

713-500-7531Zsuzsanna.H.McMahan@uth.tmc.edu

Ashish P Balar, MBBS, MPH

713-500-4409Ashish.P.Balar@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Zsuzsanna McMahan, MD, MHS

713-500-7531Zsuzsanna.H.McMahan@uth.tmc.edu

Ashish P Balar, MBBS, MPH

713-500-4409Ashish.P.Balar@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Systemic Sclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-08.