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)


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 NSAIDs 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™ (sucralose), Nutrasweet™ (aspartame), foods containing lactulose or mannitol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

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