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

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Serum-derived Bovine Immunoglobulin / Protein Isolate; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • North Little Rock
  • Florida
    • Hollywood, Florida, United States, 30021
      • Hollywood
    • Winter Park, Florida, United States, 32789
      • Winter Park
  • Maryland
    • Hagerstown, Maryland, United States, 21742
      • Hagerstown
  • New York
    • New York, New York, United States, 10021
      • Manhattan
    • New York, New York, United States, 10028
      • Manhattan
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SBI 10 g BID; Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day	Other: Serum-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.; Other Names: EnteraGam
Placebo Comparator: Placebo BID; Placebo w/control protein	Other: Placebo; Matching placebo with control hydrolyzed gelatin protein. Two packets BID.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Change in plasma albumin levels	12 weeks
Change in body mass index	12 weeks
Change in Quality of Life (SF-36)	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Entera Health, Inc
• Investigators: Study Director: Audrey L Shaw, PhD, Entera Health, Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; IBD; Crohn's; Crohns; SBI; Serum-derived bovine immunoglobulin / protein isolate; EnteraGam
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: EH6112