Retrospective Study of IBS-D Patients Previously Receiving SBI



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:December 2015
End Date:October 2016
Contact:Bruce P. Burnett, PhD
Email:Bruce.Burnett@EnteraHealth.com
Phone:954-299-1105

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Retrospective Study of Irritable Bowel Syndrome With Diarrhea (IBS-D) Patients Previously Receiving Serum-derived Bovine Serum Immunoglobulin (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., 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.

- The first collection of information (Visit 1 - Chart Report Form) will be for the visit
at which the SOC therapy, utilized immediately before the introduction of EnteraGam,
was initiated. This data point will serve as the baseline for that SOC therapy.

- The second collection of information (Visit 2 - Chart Report Form) will be for the
visit at which the original prescription for EnteraGam was written and the patient was
instructed to begin the therapy. Captured data will consist of information contained in
the patient's chart for a minimum of eight weeks and a maximum of 12 weeks prior to
initiation of EnteraGam therapy. This data point will serve as the baseline for
initiation of EnteraGam therapy.

- The third collection point (Visit 3 - Chart Report Form) will be at the next patient
visit to the clinic - provided that visit is a minimum of eight weeks following
initiation of EnteraGam therapy.

Inclusion Criteria:

- Patient is at least 18 years of age at the initiation of EnteraGam therapy.

- Patient has been previously diagnosed with IBS-D by the physician and has undergone
at least one course of SOC treatment prior to receiving EnteraGam.

- Patient has completed a minimum of eight weeks of EnteraGam therapy for his / her
IBS-D.

- There is recorded information regarding patient response to SOC or EnteraGam for
stool frequency/consistency and abdominal pain

Exclusion Criteria:

- Patient has not taken EnteraGam for a minimum of eight weeks or has not used the
product according to the directions provided by the prescribing physician.

- Patient has not consented to the use of their clinical data in this retrospective
clinical investigation.
We found this trial at
16
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