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

Mayo Clinic

Status: Completed

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Treatments: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02163213

14-002151

Details and patient eligibility

About

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.

Full 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,

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Serum Bovine Immunoglobulin

Other group

Description:

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

Treatment:

Other: Serum-derived bovine immunoglobulin protein isolate (SBI)