Retrospective Study of IBS-D Patients Previously Receiving SBI

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.

Study Overview

• Status: Completed
• Conditions: Diarrhoea Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Other: EnteraGam

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.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
    • Hamdon, Connecticut, United States, 06518
  • Florida
    • Coral Springs, Florida, United States, 33065
    • Maitland, Florida, United States, 32751
    • Orlando, Florida, United States, 32836
    • Tampa, Florida, United States, 33626
    • Winter Park, Florida, United States, 32789
  • Georgia
    • Smyrna, Georgia, United States, 30080
  • Maryland
    • Columbia, Maryland, United States, 21045
  • Missouri
    • St. Louis, Missouri, United States, 63141
  • New York
    • Lynbrook, New York, United States, 11563
    • New York, New York, United States, 10065
  • Tennessee
    • Kingsport, Tennessee, United States, 37663
    • Knoxville, Tennessee, United States, 37923
    • Morristown, Tennessee, United States, 37814
  • Texas
    • Bedford, Texas, United States, 76022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have failed on Standard of Care and then taken EnteraGam for management of their IBS-D for at least eight weeks.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care
EnteraGam	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.; 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

Collaborators and Investigators

• Sponsor: Entera Health, Inc
• Investigators: Principal Investigator: Larry Good, MD, South Nassau Communities Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: IBS; IBS-D
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulins
• Other Study ID Numbers: EH MA 1010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No