Clinical trial NCT02649075: To Evaluate SBI in the Dietary Management of Mild to Moderate Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn's Disease
Keywords: IBD
Inflammatory Bowel Disease
Crohn's
Crohns
SBI
Serum-derived bovine immunoglobulin / protein isolate
EnteraGam
Lead sponsor: Entera Health, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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®

Primary outcomes:
measure: Change in the number of liquid and soft stools
timeFrame: 12 weeks
measure: Change in abdominal pain intensity score
timeFrame: 12 weeks
measure: Change in fecal calprotectin
timeFrame: 12 weeks
measure: Change in C-reactive protein (CRP)
timeFrame: 12 weeks
measure: Change in Crohn's Disease Activity Index (CDAI)
timeFrame: 12 weeks
measure: Change in plasma albumin levels
timeFrame: 12 weeks
measure: Change in body mass index
timeFrame: 12 weeks
measure: Change in weight
timeFrame: 12 weeks
measure: Change in Quality of Life (SF-36)
timeFrame: 12 weeks
Secondary outcomes:
measure: Assess the incidence of adverse events (AEs) and serious AEs (SAEs)
timeFrame: 12 and 24 weeks
measure: Measure clinically significant changes from baseline in vital signs
timeFrame: 12 and 24 weeks
measure: Clinically significant changes from baseline in laboratory testing
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: North Little Rock
state: Arkansas
city: Hollywood
country: United States
facility: Hollywood
state: Florida
city: Winter Park
country: United States
facility: Winter Park
state: Florida
city: Hagerstown
country: United States
facility: Hagerstown
state: Maryland
city: New York
country: United States
facility: Manhattan
state: New York
city: New York
country: United States
facility: Manhattan
state: New York
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
Study officials:
affiliation: Entera Health, Inc
name: Audrey L Shaw, PhD
role: STUDY_DIRECTOR
References: