Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Early Phase 1

Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome

NCT06326645 · View on ClinicalTrials.gov ↗

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

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06326645

The ClinicalTrials.gov registry entry for NCT06326645 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lindsey Russell, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06326645 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06326645?

The interventions under investigation include: Crofelemer Oral Product (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06326645?

This trial is sponsored by Lindsey Russell, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial