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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is an open label study evaluating the impact of SBI 5.0 g twice daily on nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio), intestinal permeability (in vivo) and 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,

Official Title
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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)

Conditions
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Diarrhea-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Serum-derived bovine immunoglobulin protein isolate (SBI)


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Serum Bovine Immunoglobulin<br>Serum-Derived Bovine Immunoglobulin (SBI) 5.0 g by mouth twice daily; Effects of SBI will be compared with observations and measurements performed at baseline PRIOR to starting the SBI treatment | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)<br>* Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in epithelial barrier function, and mucosal expression of barrier-associated genes | The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency. | The secondary endpoints for the study is change from baseline in amino acid metabolism | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, irritable bowel syndrome