Diarrhoea Predominant Irritable Bowel SyndromeNCT02661425
Retrospective Study of IBS-D Patients Previously Receiving SBI
An observational study of Diarrhoea Predominant Irritable Bowel Syndrome, run by Entera Health, Inc at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhoea Predominant Irritable Bowel Syndrome
- What is being tested?
- EnteraGam
- How many people
- 165 participants
- Where
- 16 sitesUnited States
- Study dates
- Dec 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Bedford, Texas, 76022
Study site
Columbia, Maryland, 21045
Study site
Coral Springs, Florida, 33065
Study site
Greenwich, Connecticut, 06830
Study site
Hamdon, Connecticut, 06518
Study site
Kingsport, Tennessee, 37663
Study site
Knoxville, Tennessee, 37923
Study site
Lynbrook, New York, 11563
Study site
Maitland, Florida, 32751
Study site
Morristown, Tennessee, 37814
Study site
New York, New York, 10065
Study site
Orlando, Florida, 32836
Study site
Smyrna, Georgia, 30080
Study site
St Louis, Missouri, 63141
Study site
Tampa, Florida, 33626
Study site
Winter Park, Florida, 32789
About this study
Official title: Retrospective Study of Irritable Bowel Syndrome With Diarrhea (IBS-D) Patients Previously Receiving Serum-derived Bovine Serum Immunoglobulin (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.
Read the 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.
- Being tested
- EnteraGam
- Keywords
- IBS-D, IBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnteraGamOther
Also called Serum-Derived Bovine Immunoglobulin/Protein Isolate
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Not described | |
| EnteraGam | Not described Receives: Other: EnteraGam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: minimum of 8 weeks
Secondary outcomes (8)
Improvement in stool frequency
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in stool consistency
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in abdominal pain intensity
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in urgency
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in flatulence
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in fecal incontinence
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in bloating
Data collected from existing medical charts
Measured: minimum of 8 weeks
Improvement in fatigue
Data collected from existing medical charts
Measured: minimum of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhoea Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Good, MD, Principal investigator, South Nassau Communities Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661425
- Sponsor's protocol ID
- EH MA 1010
- Status last verified
- Aug 2016
- First submitted
- 19 Jan 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Irritable Bowel Syndrome With Diarrhea (IBS-D) Patients Previously Receiving Serum-derived Bovine Serum Immunoglobulin (SBI)
- ClinicalTrials.gov ID
- NCT02661425
- Acronym / sponsor ID
- EH MA 1010
- Keywords
- IBS-D, IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Entera Health, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | – |
| EnteraGam | – | Other: EnteraGam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnteraGamAlso: Serum-Derived Bovine Immunoglobulin/Protein IsolateSerum-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 | EnteraGam |
Primary outcome
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
8 secondary outcomes
Improvement in stool frequency
Time frame: minimum of 8 weeks
Improvement in stool consistency
Time frame: minimum of 8 weeks
Improvement in abdominal pain intensity
Time frame: minimum of 8 weeks
Improvement in urgency
Time frame: minimum of 8 weeks
Improvement in flatulence
Time frame: minimum of 8 weeks
Improvement in fecal incontinence
Time frame: minimum of 8 weeks
Improvement in bloating
Time frame: minimum of 8 weeks
Improvement in fatigue
Time frame: minimum of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Diarrhoea Predominant Irritable Bowel Syndrome
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea
Not yet recruitingPhase 3
Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
Diarrhea-predominant Irritable Bowel Syndrome
Not yet recruitingPhase 3
Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)
IBS, Diarrhea Predominant
Recruiting
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Good, MD principal investigator
South Nassau Communities Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhoea Predominant Irritable Bowel Syndrome, run by Entera Health, Inc at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.