Status:
ACTIVE_NOT_RECRUITING
Pilot Study of the Physiological Effects of an Integrative Medicine Approach in Irritable Bowel Syndrome
Lead Sponsor:
Thomas Jefferson University
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
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) po...
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 import...
Eligibility Criteria
Inclusion
- Inclusion Criteria for IBS Subjects:
- 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.
- Inclusion criteria for Healthy Controls:
- 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.
- Exclusion Criteria for IBS Subjects and Healthy Controls:
- 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.
Exclusion
Key Trial Info
Start Date :
May 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03370614
Start Date
May 4 2017
End Date
June 30 2025
Last Update
November 29 2024
Active Locations (2)
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1
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, United States, 19107
2
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, United States, 19085