Study Stopped
Lack of enrollment.
To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
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
1 other identifier
interventional
7
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
7 active sites
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
First Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 4, 2017
October 1, 2017
1.5 years
October 12, 2015
October 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Change in the number of liquid and soft stools
12 weeks
Change in abdominal pain intensity score
12 weeks
Change in fecal calprotectin
12 weeks
Change in C-reactive protein (CRP)
12 weeks
Change in Crohn's Disease Activity Index (CDAI)
12 weeks
Change in plasma albumin levels
12 weeks
Change in body mass index
12 weeks
Change in weight
12 weeks
Change in Quality of Life (SF-36)
12 weeks
Secondary Outcomes (3)
Assess the incidence of adverse events (AEs) and serious AEs (SAEs)
12 and 24 weeks
Measure clinically significant changes from baseline in vital signs
12 and 24 weeks
Clinically significant changes from baseline in laboratory testing
12 and 24 weeks
Study Arms (2)
SBI 10 g BID
ACTIVE COMPARATORSerum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day
Placebo BID
PLACEBO COMPARATORPlacebo w/control protein
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
North Little Rock
North Little Rock, Arkansas, 72117, United States
Hollywood
Hollywood, Florida, 30021, United States
Winter Park
Winter Park, Florida, 32789, United States
Hagerstown
Hagerstown, Maryland, 21742, United States
Manhattan
New York, New York, 10021, United States
Manhattan
New York, New York, 10028, United States
Cincinnati
Cincinnati, Ohio, 45219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Audrey L Shaw, PhD
Entera Health, Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
January 7, 2016
Study Start
February 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
October 4, 2017
Record last verified: 2017-10