Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
NCT ID: NCT02163213
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2014-06-30
2016-11-02
Brief Summary
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Detailed Description
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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,
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael Camilleri
M.D.
Principal Investigators
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Michael Camilleri, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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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.
Other Identifiers
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14-002151
Identifier Type: -
Identifier Source: org_study_id