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

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ClinicalTrials.gov Identifier: NCT02163213
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date November 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Change in epithelial barrier function, and mucosal expression of barrier-associated genes [ Time Frame: 10 weeks ]
The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin)
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Change in small bowel permeability [ Time Frame: 10 weeks ]
    The primary endpoints for the study is change from baseline in serum tryptophan metabolism (Kyneurenine/Tryptophan [K/T] ratio)
  • Change in small bowel permeability [ Time Frame: 10 weeks ]
    The primary endpoints for the study is change from baseline in small intestinal permeability (0-2h mannitol excretion)
  • Change in small bowel permeability [ Time Frame: 10 weeks ]
    The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency. [ Time Frame: 10 weeks ]
The secondary endpoints for the study is change from baseline in amino acid metabolism
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency. [ Time Frame: 10 weeks ]
    The secondary endpoints for the study is change from baseline in amino acid metabolism
  • Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency. [ Time Frame: 10 weeks ]
    The secondary endpoints for the study is change from baseline in body measurements: weight and body mass index
  • Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency. [ Time Frame: 10 weeks ]
    The secondary endpoints for the study is change from baseline in stool frequency, stool consistency (using the Bristol stool scale), abdominal pain
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2015)
Duodenal and fecal microbiomes [ Time Frame: 10 weeks ]
Exploratory endpoints: Duodenal biopsy microbiome
Original Other Pre-specified Outcome Measures
 (submitted: June 11, 2014)
  • Duodenal and fecal microbiomes [ Time Frame: 10 weeks ]
    Exploratory endpoints: Duodenal biopsy microbiome
  • Duodenal and fecal microbiomes [ Time Frame: 10 weeks ]
    Exploratory endpoints: Fecal microbiome
  • Duodenal and fecal microbiomes [ Time Frame: 10 weeks ]
    Exploratory endpoints: Immunofluorescence and electron microscopy of epithelial tight junctions
  • Duodenal and fecal microbiomes [ Time Frame: 10 weeks ]
    Exploratory endpoints: Serum levels of 7-hydroxy-4-cholesten-3-one (C4; a surrogate for bile acidsynthesis) and fibroblast growth factor (FGF) 19 (an ileal hormone that downregulates bile acid synthesis)
 
Descriptive Information
Brief Title  ICMJE Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
Official Title  ICMJE 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)
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

  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,

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diarrhea-predominant Irritable Bowel Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE 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

Intervention: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2014)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2, 2016
Actual Primary Completion Date November 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163213
Other Study ID Numbers  ICMJE 14-002151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Camilleri, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Camilleri, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP