An observational study in Irritable Bowel Syndrome, sponsored by Thomas Jefferson University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Thomas Jefferson University · Observational
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.
Subjects will be recruited only if they experience symptoms of IBS.
Inclusion Criteria for IBS Subjects:
Inclusion criteria for Healthy Controls:
Exclusion Criteria for IBS Subjects and Healthy Controls:
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 complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan.
Other: Healthy Control Group
Participants will receive approximately 2 months of dietary and nutritional counseling.
Participants will not receive any dietary or nutritional counseling.
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.
Time frame: Baseline and 2 months
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.
Time frame: Baseline and 2 months
Beck Depression Inventory.
This assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 2 months
Self-Evaluation Questionnaire
This assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Time frame: Baseline and 2 months
Symptom Diary
This assessment questionnaire will be used as one of the evaluation questionnaires for the study.
Time frame: Baseline and 2 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University