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)

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Serum Bovine Immunoglobulin; 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); Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duodenal and fecal microbiomes	Exploratory endpoints: Duodenal biopsy microbiome	10 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

General Publications

• Wang XJ, Carlson P, Chedid V, Maselli DB, Taylor AL, McKinzie S, Camilleri M. Differential mRNA Expression in Ileal Mucosal Biopsies of Patients With Diarrhea- or Constipation-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2021 Apr 12;12(4):e00329. doi: 10.14309/ctg.0000000000000329.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 2, 2016

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: diarrhea; irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: 14-002151