Retrospective Study of IBS-D Patients Previously Receiving SBI

Completed

Conditions studied: Diarrhoea Predominant Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT02661425

Run by

Entera Health, Inc

People needed

165

Starts

2015-12-01

Expected to finish

2016-09-01

Last updated by the study team

2016-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Greenwich, Connecticut, United States
• Study site — Hamdon, Connecticut, United States
• Study site — Coral Springs, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Smyrna, Georgia, United States
• Study site — Columbia, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Lynbrook, New York, United States
• Study site — New York, New York, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Morristown, Tennessee, United States
• Study site — Bedford, Texas, United States

Full record on ClinicalTrials.gov

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