Clinical trial NCT02661425: Retrospective Study of IBS-D Patients Previously Receiving SBI
Official title: Retrospective Study of Irritable Bowel Syndrome With Diarrhea (IBS-D) Patients Previously Receiving Serum-derived Bovine Serum Immunoglobulin (SBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhoea Predominant Irritable Bowel Syndrome
Keywords: IBS-D
IBS
Lead sponsor: Entera Health, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in the combined score for stool frequency/consistency and abdominal pain intensity during the time that the patient is receiving EnteraGam.
timeFrame: minimum of 8 weeks
Secondary outcomes:
measure: Improvement in stool frequency
timeFrame: minimum of 8 weeks
measure: Improvement in stool consistency
timeFrame: minimum of 8 weeks
measure: Improvement in abdominal pain intensity
timeFrame: minimum of 8 weeks
measure: Improvement in urgency
timeFrame: minimum of 8 weeks
measure: Improvement in flatulence
timeFrame: minimum of 8 weeks
measure: Improvement in fecal incontinence
timeFrame: minimum of 8 weeks
measure: Improvement in bloating
timeFrame: minimum of 8 weeks
measure: Improvement in fatigue
timeFrame: minimum of 8 weeks
Other outcomes:
Locations:
city: Greenwich
country: United States
state: Connecticut
city: Hamdon
country: United States
state: Connecticut
city: Coral Springs
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Smyrna
country: United States
state: Georgia
city: Columbia
country: United States
state: Maryland
city: St. Louis
country: United States
state: Missouri
city: Lynbrook
country: United States
state: New York
city: New York
country: United States
state: New York
city: Kingsport
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Morristown
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
Study officials:
affiliation: South Nassau Communities Hospital
name: Larry Good, MD
role: PRINCIPAL_INVESTIGATOR
References: