NCT02358564

Brief Summary

To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

6.1 years

First QC Date

January 30, 2015

Last Update Submit

September 2, 2021

Conditions

Irritable Bowel SyndromeVisceral Hypersensitivity

Keywords

IBSIrritable Bowel SyndromeVisceral HypersensitivityPermeabilitySmall BowelLactuloseMannitol

Outcome Measures

Primary Outcomes (1)

  • Mean Percent of complete epithelial cell loss

    72 hours

Study Arms (2)

Healthy Volunteers

ACTIVE COMPARATOR

Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.

Procedure: Gastrointestinal Permeability TestProcedure: Upper EndoscopyProcedure: Rectal Barostat and Infusion of Fats

Irritable Bowel Syndrome Patients

EXPERIMENTAL

Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.

Procedure: Gastrointestinal Permeability TestProcedure: Upper EndoscopyProcedure: Rectal Barostat and Infusion of Fats

Interventions

Gastrointestinal Permeability TestPROCEDURE

This test will involve ingesting a solution followed by urinalysis

Healthy VolunteersIrritable Bowel Syndrome Patients
Upper EndoscopyPROCEDURE
Healthy VolunteersIrritable Bowel Syndrome Patients
Rectal Barostat and Infusion of FatsPROCEDURE

Feeding tube will be placed, as well as a small balloon in the rectum.

Healthy VolunteersIrritable Bowel Syndrome Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years
  • No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
  • Written informed consent

You may not qualify if:

  • Females who are pregnant or breastfeeding
  • Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
  • Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
  • Use of oral corticosteroids within the previous 6 weeks
  • Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
  • Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
  • Proton pump inhibitors.
  • Antibiotics for the preceding 60 days before the start of the study.
  • (vii) Alcohol intake beyond the recommended safe limit (\<21 unites per week)
  • Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
  • Known allergy to fluorescein
  • Inflammatory bowel diseases, celiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Madhusudan Grover, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 9, 2015

Study Start

February 1, 2015

Primary Completion

March 11, 2021

Study Completion

March 11, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)