NCT02163213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2016

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

June 9, 2014

Last Update Submit

October 16, 2017

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Keywords

diarrheairritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.

    10 weeks

Other Outcomes (1)

  • Duodenal and fecal microbiomes

    10 weeks

Study Arms (1)

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

Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

Interventions

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

Serum Bovine Immunoglobulin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 33843785DERIVED

MeSH Terms

Conditions

DiarrheaIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Michael Camilleri, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 13, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 2, 2016

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

US(1)