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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Participants will complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBS Group | Other | Participants will receive approximately 2 months of dietary and nutritional counseling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined PET/MRI to define IBS activity and inflammation pattern. | To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation for IBS patients. | Baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders. | Patterns will be compared between those who respond and those who do not respond to dietary/nutritional program. | Baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory. | This assessment questionnaire will be used as one of the evaluation questionnaires for the study. | Baseline and 2 months |
| Standard Form (SF) 36 | This 36 item assessment questionnaire will be used as one of the evaluation questionnaires for the study. |
Inclusion Criteria for IBS Subjects:
Inclusion criteria for Healthy Controls:
Exclusion Criteria for IBS Subjects and Healthy Controls:
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Subjects will be recruited only if they experience symptoms of IBS.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew B. Newberg, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University, Marcus Institute of Integrative Health Centers | Philadelphia | Pennsylvania | 19107 | United States | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2019 | Nov 23, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Healthy Control Group | Other | Participants will not receive any dietary or nutritional counseling. |
|
| Baseline and 2 months |
| Profile of Mood Scale | 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 | This assessment questionnaire will be used as one of the evaluation questionnaires for the study. | Baseline and 2 months |
| Symptom Diary | This assessment questionnaire will be used as one of the evaluation questionnaires for the study. | Baseline and 2 months |
| Thomas Jefferson University, Marcus Institute of Integrative Health Centers |
| Villanova |
| Pennsylvania |
| 19085 |
| United States |
| D004066 | Digestive System Diseases |