To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02649075
• Other study ID #: EH6112
• Status: Terminated
• Phase: N/A
• First received: October 12, 2015
• Last updated: October 2, 2017
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Entera Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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.
• Placebo
Matching placebo with control hydrolyzed gelatin protein. Two packets BID.

Locations

Country	Name	City	State
United States	Cincinnati	Cincinnati	Ohio
United States	Hagerstown	Hagerstown	Maryland
United States	Hollywood	Hollywood	Florida
United States	Manhattan	New York	New York
United States	Manhattan	New York	New York
United States	North Little Rock	North Little Rock	Arkansas
United States	Winter Park	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Entera Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of liquid and soft stools		12 weeks
Primary	Change in abdominal pain intensity score		12 weeks
Primary	Change in fecal calprotectin		12 weeks
Primary	Change in C-reactive protein (CRP)		12 weeks
Primary	Change in Crohn's Disease Activity Index (CDAI)		12 weeks
Primary	Change in plasma albumin levels		12 weeks
Primary	Change in body mass index		12 weeks
Primary	Change in weight		12 weeks
Primary	Change in Quality of Life (SF-36)		12 weeks
Secondary	Assess the incidence of adverse events (AEs) and serious AEs (SAEs)		12 and 24 weeks
Secondary	Measure clinically significant changes from baseline in vital signs		12 and 24 weeks
Secondary	Clinically significant changes from baseline in laboratory testing		12 and 24 weeks