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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02649075

Run by

Entera Health, Inc

People needed

7

Starts

2016-02-01

Expected to finish

2017-08-01

Last updated by the study team

2017-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• 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®

Where it is running

• North Little Rock — North Little Rock, Arkansas, United States
• Hollywood — Hollywood, Florida, United States
• Winter Park — Winter Park, Florida, United States
• Hagerstown — Hagerstown, Maryland, United States
• Manhattan — New York, New York, United States
• Manhattan — New York, New York, United States
• Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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