Back to resultsTo Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serum-derived Bovine Immunoglobulin / Protein Isolate
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Crohn's Disease focused on measuring IBD, Inflammatory Bowel Disease, Crohn's, Crohns, SBI, Serum-derived bovine immunoglobulin / protein isolate, EnteraGam
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of mild to moderate Crohn's disease for at least 3 months.
- Screening CDAI between >150 and ≤ 250 based on subject recall.
- Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >1.
- Subject has at least one positive biomarker of inflammation: fecal calprotectin >100 µg/g; elevated C-reactive protein (CRP) >2 mg/dL.
Exclusion Criteria:
- Positive stool test for pathogenic bacteria including Clostridium difficile or O&P.
- Confirmed intestinal stricture with obstructive-like clinical symptoms.
- Bowel resection within the previous 6 months.
Change in medical therapy: must have been on a stable dose of
- corticosteroids (prednisone or prednisolone) less than or equal to 20 mg per day for 2 weeks prior to screening,
- budesonide less than or equal to 9 mg per day for 2 weeks prior to screening,
- 5-aminosalicylates for 2 weeks prior to screening, and
- immunomodulators for 6 weeks prior to screening.
- Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
- Received biologic therapy in past 2 years.
- Diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms.
- Serious infection in the 3 months prior to enrollment.
- Allergy or intolerance to beef or to any ingredient used in the product.
- Participated in an investigational drug or device study within 30 days.
- Does not have access to the internet.
- Taken EnteraGam®
Sites / Locations
- North Little Rock
- Hollywood
- Winter Park
- Hagerstown
- Manhattan
- Manhattan
- Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
SBI 10 g BID
Placebo BID
Arm Description
Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day
Placebo w/control protein
Outcomes
Primary Outcome Measures
Change in the number of liquid and soft stools
Change in abdominal pain intensity score
Change in fecal calprotectin
Change in C-reactive protein (CRP)
Change in Crohn's Disease Activity Index (CDAI)
Change in plasma albumin levels
Change in body mass index
Change in weight
Change in Quality of Life (SF-36)
Secondary Outcome Measures
Assess the incidence of adverse events (AEs) and serious AEs (SAEs)
Measure clinically significant changes from baseline in vital signs
Clinically significant changes from baseline in laboratory testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02649075
Brief Title
To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study Evaluating Serum-Derived Bovine Immunoglobulin / Protein Isolate in the Dietary Management of Mild to Moderate Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment.
Study Start Date
February 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entera Health, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the nutritional therapy with SBI (a medical food) as compared to placebo in the clinical dietary management of mild to moderate Crohn's disease.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center, pilot study evaluating SBI 10 g BID compared to matching placebo for 12 weeks followed by a 12 week open-label extension SBI 10 g BID (EnteraGam) in the dietary management of mild to moderate Crohn's disease.
The effect of SBI will be evaluated on Crohn's disease related symptoms and inflammation symptom control as measured by Crohn's disease activity index (CDAI) scores and plasma and stool markers of inflammation. The patient's quality of life will also be assessed as an indicator of disease state.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
IBD, Inflammatory Bowel Disease, Crohn's, Crohns, SBI, Serum-derived bovine immunoglobulin / protein isolate, EnteraGam
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBI 10 g BID
Arm Type
Active Comparator
Arm Description
Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Placebo w/control protein
Intervention Type
Other
Intervention Name(s)
Serum-derived Bovine Immunoglobulin / Protein Isolate
Other Intervention Name(s)
EnteraGam
Intervention Description
Serum-derived bovine immunoglobulin protein isolate (SBI) is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. Two packets (each packet contains 5 g of SBI) BID.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
Primary Outcome Measure Information:
Title
Change in the number of liquid and soft stools
Time Frame
12 weeks
Title
Change in abdominal pain intensity score
Time Frame
12 weeks
Title
Change in fecal calprotectin
Time Frame
12 weeks
Title
Change in C-reactive protein (CRP)
Time Frame
12 weeks
Title
Change in Crohn's Disease Activity Index (CDAI)
Time Frame
12 weeks
Title
Change in plasma albumin levels
Time Frame
12 weeks
Title
Change in body mass index
Time Frame
12 weeks
Title
Change in weight
Time Frame
12 weeks
Title
Change in Quality of Life (SF-36)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Assess the incidence of adverse events (AEs) and serious AEs (SAEs)
Time Frame
12 and 24 weeks
Title
Measure clinically significant changes from baseline in vital signs
Time Frame
12 and 24 weeks
Title
Clinically significant changes from baseline in laboratory testing
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of mild to moderate Crohn's disease for at least 3 months.
Screening CDAI between >150 and ≤ 250 based on subject recall.
Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >1.
Subject has at least one positive biomarker of inflammation: fecal calprotectin >100 µg/g; elevated C-reactive protein (CRP) >2 mg/dL.
Exclusion Criteria:
Positive stool test for pathogenic bacteria including Clostridium difficile or O&P.
Confirmed intestinal stricture with obstructive-like clinical symptoms.
Bowel resection within the previous 6 months.
Change in medical therapy: must have been on a stable dose of
corticosteroids (prednisone or prednisolone) less than or equal to 20 mg per day for 2 weeks prior to screening,
budesonide less than or equal to 9 mg per day for 2 weeks prior to screening,
5-aminosalicylates for 2 weeks prior to screening, and
immunomodulators for 6 weeks prior to screening.
Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
Received biologic therapy in past 2 years.
Diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms.
Serious infection in the 3 months prior to enrollment.
Allergy or intolerance to beef or to any ingredient used in the product.
Participated in an investigational drug or device study within 30 days.
Does not have access to the internet.
Taken EnteraGam®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey L Shaw, PhD
Organizational Affiliation
Entera Health, Inc
Official's Role
Study Director
Facility Information:
Facility Name
North Little Rock
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
30021
Country
United States
Facility Name
Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Hagerstown
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
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To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
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