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NCT06827977
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
Phase 2 trial testing PRIM-DJ2727 in Constipation in 21 participants. Currently enrolling.
30 May 2026
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 3 March 2025 |
| Primary completion | 30 May 2026 |
| Estimated completion | 26 September 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PRIM-DJ2727 — full drug profile →
- Placebo
Conditions studied
- Constipation — all drugs for Constipation →
- Bloating — all drugs for Bloating →
Sponsor
The University of Texas Health Science Center, Houston
Who can join
18 and older, any sex, with Constipation or Bloating. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06827977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PRIM-DJ2727
Trials testing the same drug.
- NCT04371653 — A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the · Phase 2 · withdrawn
- NCT04373473 — Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of · Phase 2 · recruiting
- NCT04729790 — Randomized Clinical Trial of Standard FMT Treatments · Phase 2 · withdrawn
- NCT03671785 — Study of the Fecal Microbiome in Patients With Parkinson's Disease · Phase 1 · completed
- NCT03026231 — Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Constipation
Currently open trials in the same condition.
- NCT07462481 — Probiotic Improve Constipation · NA · recruiting
- NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
- NCT07215351 — Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women · NA · recruiting
- NCT07135362 — The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement · NA · recruiting
- NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · NA · recruiting
Other The University of Texas Health Science Center, Houston trials
Trials by the same sponsor.
- NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente · Phase 4 · not yet recruiting
- NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
- NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
- NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
- NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06827977 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
- Last refreshed: 26 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06827977.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing