Retrospective Study of IBS-D Patients Previously Receiving SBI
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., 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.