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)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: IV What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 14-002151
NCT ID: NCT02163213
Sponsor Protocol Number: 14-002151
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.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- 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
- 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 NSAIDs 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™ (sucralose), Nutrasweet™ (aspartame), foods containing lactulose or mannitol.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.