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



Status:Enrolling by invitation
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/7/2018
Start Date:May 4, 2017
End Date:May 3, 2020

Use our guide to learn which trials are right for you!

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.

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.
We found this trial at
2
sites
925 Chestnut Street
Philadelphia, Pennsylvania 19107
Principal Investigator: Andrew B Newberg, MD
Phone: 215-503-3423
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
789 Lancaster Avenue
Villanova, Pennsylvania 19085
Phone: 215-503-3423
?
mi
from
Villanova, PA
Click here to add this to my saved trials