NCT02661425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 12, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

January 19, 2016

Last Update Submit

September 9, 2016

Conditions

Diarrhoea Predominant Irritable Bowel Syndrome

Keywords

IBS-DIBS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Improvement in stool frequency

    minimum of 8 weeks

  • Improvement in stool consistency

    minimum of 8 weeks

  • Improvement in abdominal pain intensity

    minimum of 8 weeks

  • Improvement in urgency

    minimum of 8 weeks

  • Improvement in flatulence

    minimum of 8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Standard of Care

EnteraGam

Other: EnteraGam

Interventions

EnteraGamOTHER

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.

Also known as: Serum-Derived Bovine Immunoglobulin/Protein Isolate
EnteraGam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Greenwich, Connecticut, 06830, United States

Location

Unknown Facility

Hamdon, Connecticut, 06518, United States

Location

Unknown Facility

Coral Springs, Florida, 33065, United States

Location

Unknown Facility

Maitland, Florida, 32751, United States

Location

Unknown Facility

Orlando, Florida, 32836, United States

Location

Unknown Facility

Tampa, Florida, 33626, United States

Location

Unknown Facility

Winter Park, Florida, 32789, United States

Location

Unknown Facility

Smyrna, Georgia, 30080, United States

Location

Unknown Facility

Columbia, Maryland, 21045, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Lynbrook, New York, 11563, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Kingsport, Tennessee, 37663, United States

Location

Unknown Facility

Knoxville, Tennessee, 37923, United States

Location

Unknown Facility

Morristown, Tennessee, 37814, United States

Location

Unknown Facility

Bedford, Texas, 76022, United States

Location

Study Officials

  • Larry Good, MD

    South Nassau Communities Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 22, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 12, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(16)