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

Mayo Clinic15 enrolled

Overview

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.

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,

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Serum-derived bovine immunoglobulin protein isolate (SBI)OTHER

Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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)

Time frame: 10 weeks

Secondary Outcomes

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

Time frame: 10 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.