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

Active, not recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: IBS Group; Other: Healthy Control Group

• Registration Number: NCT03370614
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2017-05-04
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBS Group	IBS Group	Participants will complete initial baseline and follow up IBS evaluations and questionnaires. Pre and Post FDG-PET-MR scans will be conducted to evaluate changes at baseline and approximately 2 months after dietary and nutritional counseling.
Healthy Control Group	Healthy Control Group	Participants will complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan.

Primary Outcome Measures

Name	Time	Method
Combined PET/MRI to define IBS activity and inflammation pattern.	Baseline and 2 months	To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation for IBS patients.

Secondary Outcome Measures

Name	Time	Method
Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.	Baseline and 2 months	Patterns will be compared between those who respond and those who do not respond to dietary/nutritional program.

Trial Locations

Locations (1)

Thomas Jefferson University, Marcus Institute of Integrative Health Centers; 🇺🇸 Villanova, Pennsylvania, United States