NCT02163213

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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,

Conditions

• Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Serum-derived bovine immunoglobulin protein isolate (SBI)	Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-02
• First posted: 2014-06-13
• Last updated: 2017-10-18

Locations

1 site across 1 country: United States