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OpenTrials
Completed

NCT Number: NCT02661425

Retrospective Study of IBS-D Patients Previously Receiving SBI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Greenwich, Connecticut, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EnteraGam

Other

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.

Other names: Serum-Derived Bovine Immunoglobulin/Protein Isolate

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.

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

Secondary outcomes

  1. Improvement in stool frequency

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  2. Improvement in stool consistency

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  3. Improvement in abdominal pain intensity

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  4. Improvement in urgency

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  5. Improvement in flatulence

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  6. Improvement in fecal incontinence

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  7. Improvement in bloating

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

  8. Improvement in fatigue

    Time frame: minimum of 8 weeks

    Data collected from existing medical charts

Sponsors and collaborators

Lead sponsor

Entera Health, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2016
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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