Crohn's Disease
Conditions
Keywords
IBD, Inflammatory Bowel Disease, Crohn's, Crohns, SBI, Serum-derived bovine immunoglobulin / protein isolate, EnteraGam
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.
Interventions
OTHERSerum-derived Bovine Immunoglobulin / Protein Isolate
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.
OTHERPlacebo
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
Sponsors
Entera Health, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Quality of Life (SF-36) | 12 weeks |
| Change in plasma albumin levels | 12 weeks |
| Change in body mass index | 12 weeks |
| Change in weight | 12 weeks |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Assess the incidence of adverse events (AEs) and serious AEs (SAEs) | 12 and 24 weeks |
Countries
United States
Outcome results
None listed