Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
Completed · Not applicable
Conditions studied: Diarrhea-predominant Irritable Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT02163213
- Run by
- Mayo Clinic
- People needed
- 15
- Starts
- 2014-06-01
- Expected to finish
- 2016-11-02
- Last updated by the study team
- 2017-10-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-65y
- Male or non-pregnant female
- IBS by Rome III criteria with predominant symptom of diarrhea
- Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day
You may not qualify if…
- Intake of medications that interfere with the study
- Antibiotic within prior 2 weeks and throughout study
- Prior abdominal surgery except appendectomy
- Active gastrointestinal diagnosis other than IBS
- History of allergy or intolerance to beef or to any ingredient in the investigational product
- Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment
- 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)
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- 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.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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