Retrospective Study of IBS-D Patients Previously Receiving SBI

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Diarrhoea Predominant Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: EnteraGam


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br> | |
| EnteraGam<br> | Other: EnteraGam<br>* 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.<br>* Other names: Serum-Derived Bovine Immunoglobulin/Protein Isolate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the combined score for stool frequency/consistency and abdominal pain intensity during the time that the patient is receiving EnteraGam. | Data collected from existing medical charts | minimum of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in stool frequency | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in stool consistency | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in abdominal pain intensity | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in urgency | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in flatulence | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in fecal incontinence | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in bloating | Data collected from existing medical charts | minimum of 8 weeks | 
| Improvement in fatigue | Data collected from existing medical charts | minimum of 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS-D, IBS