A Feasibility Study For Monitoring And Recording Gastrointestinal Myoelectric Activity In Subjects With Suspected Or Diagnosed Irritable Bowel Syndrome (IBS) And Reports Of GI Pain And Asymptomatic Subjects Without IBS and GI Pain
Device Data
Collected from today forward - ProspectiveColonic Diseases+3
+ Colonic Diseases, Functional
+ Digestive System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.This single arm, prospectively enrolling, non-randomized feasibility study has been designed to transcutaneously detect and monitor myoelectric intestinal signals temporally associated with the symptoms of patients who report pain and have suspected or diagnosed IBS, and in controls [subjects without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain].
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.88 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
General Eligibility Criteria: General Inclusion Criteria Willing and able to provide informed consent; Eighteen (18) years of age or older; Willing and able to follow a specified study procedure regimen; No known allergy to commercially available food or drink required by specified study procedure regimen; Willing and able to recline and remain still during the recordings. General Exclusion Criteria Subject has an implantable device such as a pacemaker, defibrillator, nerve stimulator, insulin pump, automatic analgesic pump, or other automated implanted medical device; Known allergy to isopropyl (rubbing) alcohol; Known allergy to Ag/AgCl electrodes; Known allergy to glue adhesive (electrode adhesive); Dietary restrictions not permitting intake of food or drink required by this protocol; Dietary restrictions not permitting four (4) hour fasting period prior to start of myoelectric recording; Subject is pregnant or suspects pregnancy; Open sores or wounds on the abdomen; Any injury in or around the area of electrode placement that would cause pain with gentle pressure required for electrode and lead wire placement; Weight > 300 lbs (136 Kg) (excess weight can interfere with quality of the signals). IBS With Complaints of GI Pain Eligibility Criteria IBS With Complaints of Pain Inclusion Criteria All answers must be "YES" to the All of the Following Inclusion Criteria Prior diagnosis of IBS and complaints of GI pain IBS With Complaints of Pain Exclusion Criteria All answers must be "NO" to the All of the Following Exclusion Criteria Functional dyspepsia; No reports of GI pain, past or present. Control Subjects Eligibility Criteria Subjects who do NOT have a prior diagnosis of functional GI disorder Control Subjects Inclusion Criteria All answers must be "YES" to the All of the Following Inclusion Criteria No prior diagnosis IBS; No complaints of GI pain. Control Subjects Exclusion Criteria All answers must be "NO" to the All of the Following Exclusion Criteria Current diagnosis of any GI disorder; Current or recent complaints of GI pain.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location