Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D

This is an open label study evaluating the impact of SBI 5.0 g twice daily on

1. nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),

2. intestinal permeability (in vivo) and

3. mucosal expression of pivotal genes including tight junction, secretory mechanisms,
tissue repair proteins and chemokines status in patients with IBS-D.

Plasma, duodenal and stool samples will be collected. Fifteen eligible subjects will be
enrolled to receive SBI for 8 weeks (SBI 5.0g BID for 8 weeks).

Intestinal permeability will be measured in vivo by two sugar urine excretion(s) after oral
ingestion.

Biopsies from the distal second or third portion of the duodenum will be obtained
endoscopically, to measure mRNA expression of tight junction proteins and markers of immune
function,

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.