We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02163213
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Diarrhea-predominant Irritable Bowel Syndrome Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : June 2014
Primary Completion Date : November 1, 2016
Study Completion Date : November 2, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

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


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Duodenal and fecal microbiomes [ Time Frame: 10 weeks ]
    Exploratory endpoints: Duodenal biopsy microbiome


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163213


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic
More Information

Responsible Party: Michael Camilleri, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02163213     History of Changes
Other Study ID Numbers: 14-002151
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Michael Camilleri, Mayo Clinic:
diarrhea
irritable bowel syndrome

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs