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

NATerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

August 31, 2017

Study Completion Date

August 31, 2017

Conditions
Crohn's Disease
Interventions
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

Placebo

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

Trial Locations (7)

10021

Manhattan, New York

10028

Manhattan, New York

21742

Hagerstown, Hagerstown

30021

Hollywood, Hollywood

32789

Winter Park, Winter Park

45219

Cincinnati, Cincinnati

72117

North Little Rock, North Little Rock

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Entera Health, Inc

INDUSTRY

NCT02649075 - To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease | Biotech Hunter | Biotech Hunter