An Open-Label Study Evaluating the Impact of Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Twice Daily on Nutritional Status in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D.

Who is eligible to participate?

Inclusion criteria: 1. Age 18-65y 2. Male or non-pregnant female 3. IBS by Rome III criteria with predominant symptom of diarrhea 4. Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day Exclusion criteria: 1. Intake of medications that interfere with the study 2. Antibiotic within prior 2 weeks and throughout study 3. Prior abdominal surgery except appendectomy 4. Active gastrointestinal diagnosis other than IBS 5. History of allergy or intolerance to beef or to any ingredient in the investigational product 6. Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment 7. Use of tobacco products within the past six months or nonsteroidal antiinflammatory drugs or aspirin within the past week (since they all may affect intestinal permeability) 8. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies. 9. For two days prior to studies, patients are instructed to avoid ingestion of artificial sweeteners such as Splenda trademark (TM) (sucralose), Nutrasweet TM (aspartame), foods containing lactulose or mannitol.

Last updated:

9/12/2014

NCT ID:

NCT02163213

IRB Number:

14-002151