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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | |||
| EnteraGam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnteraGam | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have failed on Standard of Care and then taken EnteraGam for management of their IBS-D for at least eight weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Larry Good, MD | South Nassau Communities Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenwich | Connecticut | 06830 | United States | |||
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|
|
| 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 |
| Hamdon |
| Connecticut |
| 06518 |
| United States |
| Coral Springs | Florida | 33065 | United States |
| Maitland | Florida | 32751 | United States |
| Orlando | Florida | 32836 | United States |
| Tampa | Florida | 33626 | United States |
| Winter Park | Florida | 32789 | United States |
| Smyrna | Georgia | 30080 | United States |
| Columbia | Maryland | 21045 | United States |
| St Louis | Missouri | 63141 | United States |
| Lynbrook | New York | 11563 | United States |
| New York | New York | 10065 | United States |
| Kingsport | Tennessee | 37663 | United States |
| Knoxville | Tennessee | 37923 | United States |
| Morristown | Tennessee | 37814 | United States |
| Bedford | Texas | 76022 | United States |