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

NCT03370614 | Active Not Recruiting

• 1 other identifier: 17D.184
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Irritable Bowel Syndrome

Keywords

PET; MRI; Irritable Bowel Syndrome; Irritable Bowel; Positron emission tomography; Magnetic resonance imaging; FDG; Fluorodeoxyglucose

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.

  Baseline and 2 months

Other Outcomes (5)

• Beck Depression Inventory.

  Baseline and 2 months

• Standard Form (SF) 36

  Baseline and 2 months

• Profile of Mood Scale

  Baseline and 2 months

Study Arms (2)

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

Healthy Control Group

Participants will complete initial baseline evaluations and questionnaires. Participants will also receive a FDG-PET-MR scan.

Other: Healthy Control Group

Interventions

IBS Group OTHER

Participants will receive approximately 2 months of dietary and nutritional counseling.

IBS Group

Healthy Control Group OTHER

Participants will not receive any dietary or nutritional counseling.

Healthy Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age greater than 18 years old.
• 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.
• Patients have no other pre-existing and active significant gastrointestinal medical, neurological, or psychological disorders as per review by the PI
• 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.
• 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.
• Able to give informed consent and willing to complete the study.
• No significant current active medical conditions.
• Stable medical conditions as determined by the PI are allowed.
• No brain or body abnormalities that would affect the acquisition or analysis of the scan.

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Villanova, Pennsylvania, 19085, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Andrew B. Newberg, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: May 4, 2017
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)