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

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163213
• Other study ID #: 14-002151
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: October 16, 2017
• Start date: June 2014
• Est. completion date: November 2, 2016

Study information

• Verified date: October 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duodenal and fecal microbiomes	Exploratory endpoints: Duodenal biopsy microbiome	10 weeks
Primary	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	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