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

March 25, 2024 updated by: Thomas Jefferson University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Marcus Institute of Integrative Health Centers
      • Villanova, Pennsylvania, United States, 19085
        • Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited only if they experience symptoms of IBS.

Description

Inclusion Criteria for IBS Subjects:

  1. Age greater than 18 years old.
  2. Meets the Rome III criteria for IBS: Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following: 1) Improvement with defecation; 2) Onset associated with a change in frequency of stool; 3) Onset associated with a change in form (appearance) of stool.
  3. Patients have no other pre-existing and active significant gastrointestinal medical, neurological, or psychological disorders as per review by the PI
  4. Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes) as per review by the PI.
  5. Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month.
  6. Able to give informed consent and willing to complete the study.

Inclusion criteria for Healthy Controls:

  1. No significant current active medical conditions.
  2. Stable medical conditions as determined by the PI are allowed.
  3. No brain or body abnormalities that would affect the acquisition or analysis of the scan.

Exclusion Criteria for IBS Subjects and Healthy Controls:

  1. Previous abdominal (bowel) surgery.
  2. Not continuously taking antioxidants or anti-inflammatory medications ( to be reviewed by the PI.
  3. No other active medical conditions potentially requiring changes in treatment regimen during the study duration.
  4. Not pregnant or breast feeding
  5. Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
  6. Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
  7. Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: IBS Group
Participants will receive approximately 2 months of dietary and nutritional counseling.
Healthy Control Group
Participants will complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan.
Other: Healthy Control Group
Participants will not receive any dietary or nutritional counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory.
Time Frame: Baseline and 2 months
This assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Baseline and 2 months
Standard Form (SF) 36
Time Frame: Baseline and 2 months
This 36 item assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Baseline and 2 months
Profile of Mood Scale
Time Frame: Baseline and 2 months
The Profile of Mood States (POMS) is a questionnaire of 65 single word items that asks "How have you been feeling in the past week including today." The subjects will select their response to each word that describes a mood or feeling on a Lickert scale from 1= Not at All, 2= A Little, 3=Moderately, 4=Quite a lot, to 5=Extremely. The responses are scored to generate values for Tension, Anger, Confusion, Depression and Vigor. The higher scores indicate a greater presence of that mood or state.
Baseline and 2 months
Self-Evaluation Questionnaire
Time Frame: Baseline and 2 months
This assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Baseline and 2 months
Symptom Diary
Time Frame: Baseline and 2 months
This assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Baseline and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Andrew B. Newberg, MD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17D.184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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