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NCT06827977 · ClinicalTrials.gov registry record · Phase 2
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis
A Phase 2 study of Constipation and Bloating, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06827977: Recruiting Phase 2 study of Constipation and Bloating, sponsored by The University of Texas Health Science Center, Houston.
NCT06827977 is a Phase 2 study of Constipation and Bloating that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 21 participants, below the 205-participant average among 54 other Constipation trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06827977, a Phase 2 study of Constipation and Bloating, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This consists of 34 questions covering domains such as diarrhea, constipation, abdominal pain, nausea, bloating, gastroesophageal reflux, fecal incontinence, and emotional well-being related to GI symptoms. Each item is scored on a Likert scale ranging from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe), with higher scores indicating greater symptom severity. Domain scores are calculated as the sum of responses to items within the domain, and a total score is calculated by summing all dom
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PRIM-DJ2727
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2026-09-26 |
| Phase | Phase 2 |
What NCT06827977 shows while recruiting
NCT06827977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 205-participant average among 54 other Constipation trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06827977 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06827977 about?
NCT06827977 is a clinical study titled "A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis". 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...
What is the current status of trial NCT06827977?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2025-03-03. Estimated completion is 2026-09-26.
What conditions does trial NCT06827977 study?
This clinical trial studies the following conditions: Constipation, Bloating.
What interventions are being tested in trial NCT06827977?
The interventions under investigation include: Placebo (DRUG), PRIM-DJ2727 (DRUG).
Who is sponsoring clinical trial NCT06827977?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06827977 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06827977's enrollment target sits among peer trials
21 45th of 54 higher than 9 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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