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)
This trial is active, not recruiting.
|Condition||diarrhea-predominant irritable bowel syndrome|
|Treatment||serum-derived bovine immunoglobulin protein isolate (sbi)|
|Start date||June 2014|
|End date||November 2016|
|Trial size||15 participants|
|Trial identifier||NCT02163213, 14-002151|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Change in epithelial barrier function, and mucosal expression of barrier-associated genes
time frame: 10 weeks
Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.
time frame: 10 weeks
Male or female participants from 18 years up to 65 years old.
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.
|Official title||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)|
|Principal investigator||Michael Camilleri, MD|
|Description||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,|
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