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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.
This is an open label study evaluating the impact of SBI 5.0 g twice daily on
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serum Bovine Immunoglobulin | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum-derived bovine immunoglobulin protein isolate (SBI) | Other | Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duodenal and fecal microbiomes | Exploratory endpoints: Duodenal biopsy microbiome | 10 weeks |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33843785 | Derived | 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. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
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| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |