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COMPLETED

Retrospective Study of IBS-D Patients Previously Receiving SBI

NCT02661425 · View on ClinicalTrials.gov ↗

Study Summary

This is a retrospective study designed to gather outcomes data from existing medical charts from patients who have taken EnteraGam for management of their IBS-D for at least eight weeks. Data from two study periods will be collected: (1) the time during which the Standard of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the time during which EnteraGam is used as therapy.

Interventions

  • OTHER EnteraGam

Study Locations (16)

Florida

  • — Coral Springs
  • — Maitland
  • — Orlando
  • — Tampa
  • — Winter Park

Tennessee

  • — Kingsport
  • — Knoxville
  • — Morristown

Connecticut

  • — Greenwich
  • — Hamdon

New York

  • — Lynbrook
  • — New York

Georgia

  • — Smyrna

Maryland

  • — Columbia

Missouri

  • — St Louis

Texas

  • — Bedford

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2015-12
Est. Completion 2016-09

Sponsor

Entera Health

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02661425

The ClinicalTrials.gov registry entry for NCT02661425 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Entera Health, which has 2 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 Diarrhoea Predominant Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention — of which EnteraGam 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: NCT02661425 reports 16 study locations spanning 8 distinct geographic areas — top geographies include Florida, Tennessee, Connecticut. 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 NCT02661425 about?

NCT02661425 is a clinical study titled "Retrospective Study of IBS-D Patients Previously Receiving SBI". This is a retrospective study designed to gather outcomes data from existing medical charts from patients who have taken EnteraGam for management of their IBS-D for at least eight weeks. Data from two study periods will be collected: (1) the time during which the Standard of Care (SOC) therapy (i.e....

What is the current status of trial NCT02661425?

This trial is currently completed. The enrollment target is 165 participants. The study started on 2015-12. Estimated completion is 2016-09.

What conditions does trial NCT02661425 study?

This clinical trial studies the following conditions: Diarrhoea Predominant Irritable 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 NCT02661425?

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

Who is sponsoring clinical trial NCT02661425?

This trial is sponsored by Entera Health, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02661425 being conducted?

This trial has 16 study locations across Connecticut, Florida, Georgia, Maryland, Missouri. 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