Retrospective Study of IBS-D Patients Previously Receiving SBI

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 2016

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

  • Other: EnteraGam
    • 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.

Arms, Groups and Cohorts

  • Standard of Care
  • EnteraGam

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Improvement in stool frequency
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in stool consistency
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in abdominal pain intensity
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in urgency
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in flatulence
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in fecal incontinence
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in bloating
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts
  • Improvement in fatigue
    • Time Frame: minimum of 8 weeks
    • Data collected from existing medical charts

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Entera Health, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Larry Good, MD, Principal Investigator, South Nassau Communities Hospital

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