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NCT06326645 · ClinicalTrials.gov registry record · Early Phase 1
Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
A Early Phase 1 study of Short Bowel Syndrome, sponsored by Lindsey Russell, MD.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06326645: Recruiting Early Phase 1 study of Short Bowel Syndrome, sponsored by Lindsey Russell, MD.
NCT06326645 is a Early Phase 1 study of Short Bowel Syndrome that is actively recruiting participants, run by Lindsey Russell, MD. The registered enrollment target is 6 participants, below the 184-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06326645, a Early Phase 1 study of Short Bowel Syndrome, is actively recruiting participants, sponsored by Lindsey Russell, MD.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. .
Primary Outcome
Change in ostomy output from baseline over the entire 12-week treatment period as average weekly ostomy output at week 12.
Conditions Studied
Interventions
- DRUG Crofelemer Oral Product
Study Locations (1)
Ohio
- Cleveland Clinic Main Campus - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2026-02-01 |
| Phase | Early Phase 1 |
What NCT06326645 shows while recruiting
NCT06326645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 184-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Crofelemer Oral Product is the first listed.
NCT06326645 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06326645 about?
NCT06326645 is a clinical study titled "Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome". The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 we...
What is the current status of trial NCT06326645?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2025-03-03. Estimated completion is 2026-02-01.
What conditions does trial NCT06326645 study?
This clinical trial studies the following conditions: Short Bowel Syndrome.
What interventions are being tested in trial NCT06326645?
The interventions under investigation include: Crofelemer Oral Product (DRUG).
Who is sponsoring clinical trial NCT06326645?
This trial is sponsored by Lindsey Russell, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06326645 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Short Bowel Syndrome
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 NCT06326645's enrollment target sits among peer trials
6 18th of 17 the lowest of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome 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
-
Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
COMPLETED · Early Phase 1
-
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
RECRUITING · NA
-
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
RECRUITING · Phase 2
-
A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
RECRUITING · NA
-
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
RECRUITING · Phase 3
-
Registry for Participants With Short Bowel Syndrome
ACTIVE NOT RECRUITING
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