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Retrospective Study of IBS-D Patients Previously Receiving SBI

NCT02661425 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2016-09-12

No results posted yet for this 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.

Conditions

  • Diarrhoea Predominant Irritable Bowel Syndrome

Interventions

OTHER

EnteraGam

Serum-derived bovine immunoglobulin/protein isolate (SBI) is the nutritional ingredient in EnteraGam. SBI contains a minimum of 50% immunoglobulin. The protein isolate is a light-colored powder. Each packet contains SBI (5.0 g) and the following inactive ingredients: dextrose (5.0 g) and a trace amount of sunflower lecithin.

Sponsors & Collaborators

  • Entera Health, Inc

    lead INDUSTRY

Principal Investigators

  • Larry Good, MD · South Nassau Communities Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661425 on ClinicalTrials.gov