Diarrhoea Predominant Irritable Bowel Syndrome
Conditions
Keywords
IBS-D, IBS
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.
Interventions
OTHEREnteraGam
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
Entera Health, Inc
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the combined score for stool frequency/consistency and abdominal pain intensity during the time that the patient is receiving EnteraGam. | minimum of 8 weeks | Data collected from existing medical charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in fecal incontinence | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in stool frequency | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in stool consistency | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in flatulence | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in urgency | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in bloating | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in fatigue | minimum of 8 weeks | Data collected from existing medical charts |
| Improvement in abdominal pain intensity | minimum of 8 weeks | Data collected from existing medical charts |
Countries
United States
Outcome results
None listed