Diarrhoea Predominant Irritable Bowel Syndrome Clinical Trial
Official title:
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.
;
Observational Model: Case Control, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02419963 -
Analyzing IBS to Identify Biomarkers and Microbiome Signatures
|
N/A |