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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 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.

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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. .

Conditions Studied

Interventions

  • DRUG Crofelemer Oral Product

Study Locations (1)

Ohio

  • Cleveland Clinic Main Campus - Cleveland

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2025-03-03
Est. Completion 2026-02-01
Phase Early Phase 1

Sponsor

Lindsey Russell, MD

1 total trials

What the Registry Record Tells You About NCT06326645

The ClinicalTrials.gov registry entry for NCT06326645 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (97% lower). The listed sponsor is Lindsey Russell, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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