Retrospective Study of IBS-D Patients Previously Receiving SBI

Completed

• Conditions: Diarrhoea Predominant Irritable Bowel Syndrome
• Interventions: Other: EnteraGam

• Registration Number: NCT02661425
• Lead Sponsor: Entera Health, Inc

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-22
• Status Verified: 2016-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EnteraGam	EnteraGam	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Improvement in stool consistency	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
Improvement in fecal incontinence	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 urgency	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 bloating	minimum of 8 weeks	Data collected from existing medical charts
Improvement in flatulence	minimum of 8 weeks	Data collected from existing medical charts