Retrospective Study of IBS-D Patients Previously Receiving SBI

Diarrhoea Predominant Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661425
• Other study ID #: EH MA 1010
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: September 9, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Entera Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Entera Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement in stool frequency	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in stool consistency	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in abdominal pain intensity	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in urgency	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in flatulence	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in fecal incontinence	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in bloating	Data collected from existing medical charts	minimum of 8 weeks	No
Secondary	Improvement in fatigue	Data collected from existing medical charts	minimum of 8 weeks	No