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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370614
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2017
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Other: IBS Group Other: Healthy Control Group

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel Syndrome
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Beck Depression Inventory. [ Time Frame: Baseline and 2 months ]
    This assessment questionnaire will be used as one of the evaluation questionnaires for the study.

  2. 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.

  3. 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.

  4. Self-Evaluation Questionnaire [ Time Frame: Baseline and 2 months ]
    This assessment questionnaire will be used as one of the evaluation questionnaires for the study.

  5. Symptom Diary [ Time Frame: Baseline and 2 months ]
    This assessment questionnaire will be used as one of the evaluation questionnaires for the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited only if they experience symptoms of IBS.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370614


Locations
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United States, Pennsylvania
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, United States, 19085
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Andrew B. Newberg, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03370614    
Other Study ID Numbers: 17D.184
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
PET
MRI
Irritable Bowel Syndrome
Irritable Bowel
Positron emission tomography
Magnetic resonance imaging
FDG
Fluorodeoxyglucose
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases