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Clinical Trials/NCT03370614
NCT03370614
Active, not recruiting
Not Applicable

Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel Syndrome

Thomas Jefferson University1 site in 1 country50 target enrollmentMay 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
Thomas Jefferson University
Enrollment
50
Locations
1
Primary Endpoint
Combined PET/MRI to define IBS activity and inflammation pattern.
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Although underutilized, what is emerging as one of the best ways of evaluating inflammation in the body, particularly in difficult to observe regions, is through the use of Fluorodeoxyglucose (FDG) positron emission tomography (PET). FDG is taken up in the body much like glucose and is particularly taken up in areas of inflammation where there is increased metabolism. Therefore, this technology can be used to assess inflammation, and measure the reduction in inflammation as the result of integrative interventions that target dietary modifications designed to reduce inflammation. With this proposed study, we plan to use FDG PET-MRI technology to develop a more specific and sensitive approach for evaluating areas of inflammation associated with IBS and measuring improvements in that inflammation in response to effective integrative interventions.

Detailed Description

The typical goal of the integrative medicine approach is to develop an individualized plan to help restore homeostasis to the gastrointestinal system targeting a reduction in inflammation as an important element in helping to relieve symptoms. One of the most problematic issues though is to determine where in the GI tract the inflammation is occurring and then evaluating improvements in inflammation as any intervention proceeds. Participants will undergo a small battery of diagnostic tests that include magnetic resonance imaging (MRI), fluorodeoxyglucose positron emission tomography (FDG-PET). A secondary goal of this study is to evaluate the utility of FDG PET-MRI for assessing reductions in inflammation in patients managed with an integrative medicine approach based upon diet and nutritional counselling.

Registry
clinicaltrials.gov
Start Date
May 4, 2017
End Date
June 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Combined PET/MRI to define IBS activity and inflammation pattern.

Time Frame: Baseline and 2 months

To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation for IBS patients.

Secondary Outcomes

  • Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.(Baseline and 2 months)

Study Sites (1)

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