Back to resultsSerum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
Primary Purpose
Diarrhea-predominant Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serum-derived bovine immunoglobulin protein isolate (SBI)
Sponsored by
About this trial
This is an interventional supportive care trial for Diarrhea-predominant Irritable Bowel Syndrome focused on measuring diarrhea, irritable bowel syndrome
Eligibility Criteria
Inclusion criteria:
- Age 18-65y
- Male or non-pregnant female
- IBS by Rome III criteria with predominant symptom of diarrhea
- Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day
Exclusion criteria:
- Intake of medications that interfere with the study
- Antibiotic within prior 2 weeks and throughout study
- Prior abdominal surgery except appendectomy
- Active gastrointestinal diagnosis other than IBS
- History of allergy or intolerance to beef or to any ingredient in the investigational product
- Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment
- 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)
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Serum Bovine Immunoglobulin
Arm 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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02163213
Brief Title
Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 2, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
This is an open label study evaluating the impact of SBI 5.0 g twice daily on
nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),
intestinal permeability (in vivo) and
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-predominant Irritable Bowel Syndrome
Keywords
diarrhea, irritable bowel syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serum Bovine Immunoglobulin
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Serum-derived bovine immunoglobulin protein isolate (SBI)
Intervention Description
Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D
Primary Outcome Measure Information:
Title
Change in epithelial barrier function, and mucosal expression of barrier-associated genes
Description
The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.
Description
The secondary endpoints for the study is change from baseline in amino acid metabolism
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Duodenal and fecal microbiomes
Description
Exploratory endpoints: Duodenal biopsy microbiome
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 18-65y
Male or non-pregnant female
IBS by Rome III criteria with predominant symptom of diarrhea
Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day
Exclusion criteria:
Intake of medications that interfere with the study
Antibiotic within prior 2 weeks and throughout study
Prior abdominal surgery except appendectomy
Active gastrointestinal diagnosis other than IBS
History of allergy or intolerance to beef or to any ingredient in the investigational product
Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment
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)
Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Camilleri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33843785
Citation
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.
Results Reference
derived
Learn more about this trial
Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
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