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

Not Applicable

Completed

• Conditions: Diarrhea-predominant Irritable Bowel Syndrome
• Interventions: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

• Registration Number: NCT02163213
• Lead Sponsor: Mayo Clinic

Brief 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,

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Primary Completion: 2016-11-01
• Study Completion: 2016-11-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serum Bovine Immunoglobulin	Serum-derived bovine immunoglobulin protein isolate (SBI)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.	10 weeks	The secondary endpoints for the study is change from baseline in amino acid metabolism

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States